Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
CareFusion 303; Inc. Aug-02-2013 Alaris PC unit; model 8015 – Alaris PC unit; model 8015; with version 9.12-Keyboard Processor and logic board assembly part number TC10006584.The Alaris PC Unit is the main user interface unit and power supply of the Alaris System; a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. CareFusion is recalling the Alaris PC units model 8015 (PC unit); version 9.12; because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.
Iradimed Corporation Aug-02-2013 MRidium 1145 Dose Reduction System (DERS) – MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System).The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before; during or after magnetic Resonance imagining (MRI) scans. The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
Hospira Inc. Aug-05-2013 Y-Type Blood Set – List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter; Cylinder Pump; CLAVE Y-Site; Non-Vented; 80 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Y-Type Blood Set – List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter; Prepierced Y-Site; Non-Vented; 80 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Plum Y-Type Blood Set – List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter; CLAVE Port; Non-Vented; 110 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Plum Blood Set – List No. 14211-28; PLUM BLOOD SET; Prepierced Port; 200 Micron Filter; 110 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Plum Blood Set – List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site; 170 Micron Filter; Prepierced Port; Non-Vented; 105 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Blood Set – List No. 14207-28; BLOOD SET; 200 Micron Filter; 105 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Blood Set – List No. 14203-28; BLOOD SET; 200 Micron Filter; 80 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Secondary Blood Set – List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter; 36 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Hospira Inc. Aug-05-2013 Y-Type Blood Set – List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter; Cylinder Pump; Convertible Pin and Non-Vented Pin; 80 Inch; Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira.; Inc.; Lake Forrest; IL 60045 USAHospira Blood sets are designed for Blood Product Administration It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Cordis Corporation Aug-07-2013 OptEase Vena Cava Filter – Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR***Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage:The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic; recurrent pulmonary embolism where anticoagulant therapy has failed; or is contraindicated. Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (50 Count InternationalCatalog Number: 45512Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (10 Count Vials)Catalog Number: 43604These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Plus Monitor System (Kit w/10 Count Vials International)Catalog Number: 45507Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (50 Count DME)Catalog Number: 43523Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (50 Count Retail)Catalog Number: 43437Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Plus Monitor System (Kit w/10 Count Vials)Catalog Number: 43435Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Glucose Test Strips (10 Count Boxed)Catalog Number: 43590Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Nova Biomedical Corporation Aug-09-2013 Nova Max Glucose Test Strips – Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max; Nova Max Plus; Nova Max Link; BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Reports of false abnormally high glucose readings from test strips
Stryker Spine Aug-22-2013 Stryker Spine Oasys Midline Occiput Plate – Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long5) Mini.Allows for positioning directly on the midline keel of the occiput. Stryker has received reports from customers indicating post-operativefracture of the pin that connects the tulip head to the plate body.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Mesa Laboratories; Inc.; Bozeman Manufacturing Facility Aug-01-2013 EZTest; Ensure; ETIGAM Bright-Cheq; ParaSure; ConFirm 24 & 10; BT Sure; Assure Accufast; Valisafe – Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. Mesa EZTest ; Self-contained steam biological indicator; are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Siemens Medical Solutions USA; Inc Aug-01-2013 Siemens Luminos dRF – Siemens Luminos dRF Fluoroscopic X-Ray systemFluoroscopic X-Ray system Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S — all four units have been corrected.
SpineFrontier; Inc. Aug-01-2013 S-LIFT Slap Hammer – S-LIFT Slap Hammer; Part Number: 11-50204; Revision AThe slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients. Malfunction of slap hammer.
GE Healthcare; LLC Aug-01-2013 GE Healthcare; LOGIQ e Ultrasound System. – GE Healthcare; LOGIQ e Ultrasound System.The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast; testes; thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal; thoracic and PV); Musculo-skeletal Conventional & Superficial; Transesophageal; Transrectal and Transvaginal; and Thoracic/Pleural for motion/sliding and fluid detection. GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
Mesa Laboratories; Inc.; Bozeman Manufacturing Facility Aug-01-2013 Mesa Labs; ETIGAM Bright-Cheq; and Getinge Assure Accufast – Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM.Intended for use in determining the efficacy of steam sterilization processes. Self-contained steam biological indicator; are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 16 x 40 mm; Syringe volume 12 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 14 x 40 mm; Syringe volume 12 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 12 x 40 mm; Syringe volume 12 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 10 x 40 mm; Syringe volume 12 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 8.5 x 24 mm; Syringe volume 12 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 5 x 24 mm; Syringe volume 6-8 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Acclarent; Inc. Aug-01-2013 Inspira AIR Balloon Dilation system – Inspira AIR Balloon Dilation system.Size 7 x 24 mm; Syringe volume 6-8 cc.Dilation of airway tree. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Hospira Inc. Aug-01-2013 1) Symbiq One Channel Infuser; 2) Symbiq Two Channel Infuser – The Hospira Symbiq Infusion System is intended for the delivery of fluids; solutions; drugs; agents; nutritionals; electrolytes; blood and blood products via parenteral; enteral; intravenous; intra-arterial; subcutaneous; epidural; or irrigation routes of administration. The devices secondary audio signal fails to activate.
SpineFrontier; Inc. Aug-01-2013 Screw Caddy; 8MM adn 9MM-PedFuse – Caddy – PedFuse; Screw Caddy; 8MM and 9MM; Part Number: 11-80009 Rev. BThe caddy holds; in an organized fashion within the case; 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws; and the holes that hold the 9mm screws are designated for 8mm screws.
Siemens Medical Solutions USA; Inc Aug-01-2013 syngo Dynamics – syngo Dynamics Information System (sDIS) versions 9.5 and VA10A.The syngo¿ Dynamics system is intended for the acceptance; transfer; display; storage; archive; and manipulation of digital medical images; including quantification and reportgeneration.syngo¿ Dynamics is not intended to be used for reading mammography images. Siemens issued a Customer Safety Advisory Notice about a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at associa
Beckman Coulter Inc. Aug-02-2013 Beckman Coulter AU5800 Clinical Chemistry Analyzer – Beckman Coulter AU5800 Clinical Chemistry Analyzer; All Serial Numbers.An automated chemistry analyzer that measures analytes in samples; in combination with appropriate reagents; calibrators; quality control (QC); material and other accessories. Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
SpineFrontier; Inc. Aug-02-2013 Drill Guide (guide; surgical; instrument) – Drill Guide – Chameleon FacetFuse Fixation System; Model: 11-00028 Rev. AFacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone; which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. Prior to use in surgery; the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result; drills and taps could not be directed down guides during surgery due to mechanical interference.
Precision Dynamics Corporation Aug-02-2013 Nonsterile Viscot Part Number 1437-100 Surgical Skin Markers – Non-sterile Viscot Surgical Skin MarkersPart Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient’s skin; e.g.; to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration. PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers; becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.
Medtronic Inc. Cardiac Rhythm Disease Management Aug-05-2013 Mullins Transseptal Catheter Introducer Sheath – Medtronic Mullins Transseptal Adult 7F; REF 008551.Intended for the introduction of cardiovascular catheters into the left side of the heart. Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath; model 008551; in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size; an 8F dilator will not
Siemens Medical Solutions USA; Inc Aug-05-2013 Mobilett Mira Mobile X-ray – Mobiletta Mira Mobile X-ray System Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators); it is possible that one of its main wheel shafts could break because of material fatigue; resulting in the chassis falling on the ground on the affected wheel side. This
ASO; LLC Aug-06-2013 HEB Wound Closure Adhesive Surgical Tape Strips – HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 041220302536Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Leader Wound Closure Adhesive Surgical Tape Strips – Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 096295114706Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Meijer Wound Closure Adhesive Surgical Tape Strips – Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 719283595973Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Premier Value Wound Closure Adhesive Surgical Tape Strips – Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 040986021558Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips – Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 093351120374Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 TopCare Wound Closure Adhesive Surgical Tape Strips – TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 036800165854Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips – Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # ("W") 311917111728 item # 479241UPC # ("Well at Walgreens") 311917143354 item # 156744Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Wound Closure Adhesive Surgical Tape Strips – CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 050428102909 item # 409170Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
ASO; LLC Aug-06-2013 Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips – Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex freeUPC # 639194043885Used to secure; close and support small cuts and wounds. This recall has been initiated by Aspen Surgical Products; Inc.; due to the inability to confirm sterility.
Stryker Instruments Div. of Stryker Corporation Aug-06-2013 Sonopet Ultrasonic Aspirator Console – Sonopet Ultrasonic Aspirator Console(Console 110V with Pedal & Pole)Product Usage:The Sonopet Console is indicated for use in surgical procedures where fragmentation; emulsification; and aspiration of soft and hard tissue is desirable; including neurosurgery; gastrointestinal and affiliated organ surgery; urological surgery; plastic and reconstructive surgery; general surgery; orthopedic surgery; gynecological surgery; thoracic surgery; laparoscopic surgery; and thoracoscopic surgery. A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. Theissue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board canpotentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigationpump is to supply sali
Stryker Instruments Div. of Stryker Corporation Aug-06-2013 Sonopet Ultrasonic Aspirator Console – Sonopet Ultrasonic Aspirator Console5450-851-000(Console 100V)Product Usage:The Sonopet Console is indicated for use in surgical procedures where fragmentation; emulsification; and aspiration of soft and hard tissue is desirable; including neurosurgery; gastrointestinal and affiliated organ surgery; urological surgery; plastic and reconstructive surgery; general surgery; orthopedic surgery; gynecological surgery; thoracic surgery; laparoscopic surgery; and thoracoscopic surgery. A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. Theissue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board canpotentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigationpump is to supply sali
Nestle HealthCare Nutrition Aug-06-2013 Compat Nasogastric Feeding Tube – Nestle Nutrition; Compat; Enteral Feeding Tube; sterile; 8 French (REF 08310400); 10 French (REF 08310600); and 12 French (REF 08310500). Product Usage:The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition; fluids and medications into the stomach r small bowel by the naso-enteric; route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs. Nestle HealthCare Nutrition; Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch; thus compromising the sterility claimed on the label.
Stryker Instruments Div. of Stryker Corporation Aug-06-2013 Sonopet Ultrasonic Aspirator Console – Sonopet Ultrasonic Aspirator Console5450-852-000 (Console 230V)Product Usage:The Sonopet Console is indicated for use in surgical procedures where fragmentation; emulsification; and aspiration of soft and hard tissue is desirable; including neurosurgery; gastrointestinal and affiliated organ surgery; urological surgery; plastic and reconstructive surgery; general surgery; orthopedic surgery; gynecological surgery; thoracic surgery; laparoscopic surgery; and thoracoscopic surgery. A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. Theissue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board canpotentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigationpump is to supply sali
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 EN. Part number: 414560.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 DE. Part number: 414539.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01ML2. Part number: 414538.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01ML1. Part number: 414537.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; V2S 6.01 RP5800-WES7 Media. Part number: 413861.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 ES. Part number: 414561.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 ZH. Part number: 414569.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 EL; TR. Part number: 414568.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 DA; SV. Part number: 414567.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 PT. Part number: 414566.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 NO. Part number: 414565.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 JA. Part number: 414564.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 IT. Part number: 414563.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Biomerieux Inc Aug-06-2013 bioMerieux Vitek 2 Systems Software version 6.01 software – bioMerieux Vitek 2 Systems Software version 6.01 software; used with the VITEK 2 automated system. Kit; UPDT V2S 6.01 FR. Part number: 414562.The product is used with the VITEK 2 automated system which consists of instruments; software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01; the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin; Prulifloxacin and Ceftaroline. For the referenced antibiotics; the firm code in the reference table
Ventana Medical Systems Inc Aug-06-2013 BenchMark ULTRA – VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use OnlyProduct Usage:Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents. Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and u
Ventana Medical Systems Inc Aug-06-2013 Discovery Ultra Advanced Staining System- Research Use Only (RUO) – VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use OnlyProduct Usage:Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents. Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter; thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu
Siemens Healthcare Diagnostics; Inc Aug-06-2013 IMMULITE Systems Rapid TSH – IMMULITE Systems Rapid TSH (REF LKRT1 – 100T; LKRT5 – 500 T; L2KRT2 – 200T; L2KRT6 – 600T).Intended to quantitatively measure human thyroid stimulating hormone (TSH; thyrotropin). A rare variant of TSH; identified in a small cluster of patients; is not detected.
Siemens Healthcare Diagnostics; Inc Aug-06-2013 Dimension TSH Flex Reagent Cartridge – Dimension TSH Flex Reagent Cartridge (REF RF412).Intended to quantitatively measure human thyroid stimulating hormone (TSH; thyrotropin). A rare variant of TSH; identified in a small cluster of patients; is not detected.
Siemens Healthcare Diagnostics; Inc Aug-06-2013 Dimension EXL LOCI Module TSHL Flex Reagent Cartridge – Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612).Intended to quantitatively measure human thyroid stimulating hormone (TSH; thyrotropin). A rare variant of TSH; identified in a small cluster of patients; is not detected.
Siemens Healthcare Diagnostics; Inc Aug-06-2013 Dimension Vista TSH Flex Reagent Cartridge – Dimension Vista System TSH Flex Reagent Cartridge (REF K6412).Intended to quantitatively measure human thyroid stimulating hormone (TSH; thyrotropin). A rare variant of TSH; identified in a small cluster of patients; is not detected.
Siemens Healthcare Diagnostics; Inc Aug-06-2013 IMMULITE Systems Third Generation TSH – IMMULITE Systems Third Generation TSH (REF LKTS1 – 100T; LKTS5 – 500T; L2KTS2 – 200T; L2KTS6 – 600T).Intended to quantitatively measure human thyroid stimulating hormone (TSH; thyrotropin). A rare variant of TSH; identified in a small cluster of patients; is not detected.
Arjo; Inc. dba ArjoHuntleigh Aug-06-2013 Enterprise 9000 Bed – Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale; patient bed exit alarm; and under bed anti-entrapment system; ArjoHuntleigh AB; Eslov; Sweden; Models 9000; 9600; 9700 and 9800General medicine; general and specialist surgery; care of the elderly; HDU; ITU; coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling. ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.
Arjo; Inc. dba ArjoHuntleigh Aug-06-2013 Enterprise 8000 Bed – Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB; Eslov; Sweden; Models 8000; 8001; 8002; 8003; 8500; 8600; 8700 and 8800General medicine; general and specialist surgery; care of the elderly; HDU; ITU; coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling. ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.
Siemens Healthcare Diagnostics; Inc Aug-06-2013 ADVIA Centaur Systems TSH3 Ultra ReadyPack – ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 – 100 Tests; REF 06491080 – 500 Tests; REF 04862625 – 2500T).Intended to quantitatively measure human thyroid stimulating hormone (TSH; thyrotropin). A rare variant of TSH; identified in a small cluster of patients; is not detected.
Becton Dickinson & Company Aug-07-2013 BD Vacutainer Multiple Sample and Direct Draw Luer Adapter – BD Vacutainer Multiple Sample and Direct Draw Luer AdapterBD Franklin Lakes; NJ 07417 USAA sterile non-invasive device used to connect venous access devices such as needles; blood collection sets; ad infusion sets to blood collection tubes. BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.
Siemens Healthcare Diagnostics; Inc. Aug-07-2013 DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107) – Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients. Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
Siemens Healthcare Diagnostics; Inc. Aug-07-2013 Dimension¿ Mass Creatine Kinase MB Isozyme Calibrator – Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420)The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module. Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs; gel-like clumps may be observed.
American Optisurgical Inc Aug-08-2013 TX1 Tissue Removal System Console – TX1 Tissue Removal System Console. Model: TX1TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation; as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections.Indiciated for use in surgical procedures where fragmentation; emulsification; and aspiration of soft tissue are desirable; including General Surgery; Orthopedic Surgery; Laparoscopic Surgery and Plastic and Reconstructive Surgery. Two reasons for recall.1. Incorrect pressure relief valve installed inside console; leading to a remote chance of a risk to health. 2. Technical Specifications; under Irrigation; the Operating Pressure value is incorrect.
SpineFrontier; Inc. Aug-08-2013 Invue Split Driver; Assembly with Handle – Invue Split Driver; Assembly with Handle; Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle; a shaft and hexalobe-like tip with a 4.0mm split; which allows the driver to collapse to fit into a screw and expand to retain the screw. Device design.
Smith & Nephew Inc Aug-08-2013 R3 (TM) XLPE ACETABULAR LINER UHMWPE; 20o OVERHANG; 36 MM ID; 62 MM OD – R3 (TM) XLPE ACETABULAR LINER UHMWPE; 20o OVERHANG; 36 MM ID; 60 MM OD; QTY: (1); STERILE H2O2; REF 71335760.Orthopaedic. One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
MITSUBISHI HEAVY INDUSTRIES; LTD.; HIROSHIMA MACHINERY WORK Aug-08-2013 MHI-TM2000/ VERO (TM) – MHI-TM2000 Linear Accelerator System; Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions; tumors and conditions anywhere in the body where radiation treatment is indicated Software anomaly: Mitsubishi Heavy Industries; Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
Smith & Nephew Inc Aug-08-2013 R3 (TM) XLPE ACETABULAR LINER UHMWPE; 20o OVERHANG; 36 MM ID; 62 MM OD – R3 (TM) XLPE ACETABULAR LINER UHMWPE; 20o OVERHANG; 36 MM ID; 62 MM OD; QTY: (1); STERILE H2O2; REF 71335762.Orthopaedic. One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Radiometer America Inc Aug-08-2013 TCM4 series Base Unit – TCM4 series Base Units; and spare part Power Supply; Radiometer Medical ApS; Akandevej 21; Br¿nsh¿j; Denmark; www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures; oxygen saturation; and pulse rate. RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
SpineFrontier; Inc. Aug-08-2013 Indus Invue Screw Caddy – Indus Invue Screw Caddy; Model: SI70097The caddy holds; in an organized fashion within the case; a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling; O4.2mm Self-Tapping; and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product. Difficulty removing screws from the Invue caddies.
SpineFrontier; Inc. Aug-08-2013 Screw inserter (screwdriver – orthopedic manual surgical instrument) – Rev E PedFuse Return Screw Inserter; Part Number: 11-80030Screw inserters are instruments which capture; hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System . Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
SpineFrontier; Inc. Aug-08-2013 T-Handle – T-Handle; Strike Plate; Push Connection; Part Number: SI50023 Rev AT-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to; and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Medtronic Xomed; Inc. Aug-09-2013 Tra; Surgical; ENT – Tray Surgical; ENT (various instrument trays)Used for stot age and transportation of reusable surgical instruments utilized in various ear; nose and throat (ENT) and head and neck surgical procedures. The firm will recall and replace the identified instrument trays in the field; with trays that have improved labeling; including lids that contain the statement indicating ‘PREVACUUM ONLY"
Siemens Medical Solutions USA; Inc Aug-09-2013 Siemens AXIOM Artis zeego – Siemens AXIOM Artis zeegox-ray; angiographic system Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
OrthoPediatrics Corp Aug-09-2013 OrthoPediatrics PediLoc Locking Plate System – 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002; 2.5mm Drill Bit; Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
Stryker Medical Division of Stryker Corporation Aug-09-2013 IsoGel Air – IsoGel AIR 84; Support Surface.Intended to assist in improving human patient outcomes. Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation; it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi
GE Healthcare; LLC Aug-09-2013 Optima XR220amx; Optima XR200amx; and Brivo XR285amx – GE Healthcare; Optima XR220amx; Optima XR200amx; and Brivo XR285amx.The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull; spinal column; chest; abdomen; extremities; and other body pants with the patient sitting; standing; or lying in the prone or supine position. These devices are not intended for mammographic applications. GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx; Optima XR200amx; and Brivo XR285amx systems) because of an Erratic Drive Performance.
GE Healthcare; LLC Aug-09-2013 LOGIQ S8 Ultrasound System – GE Healthcare; LOGIQ S8 Ultrasound SystemThe device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast; testes; thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal; thoracic; vascular and neurosurgical). GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or TimeIntensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume; Depth measur
Atrium Medical Corporation Aug-09-2013 C-QUR TacShield Mesh – C-QUR TacShield Mesh (All sizes and shapes).Intended for use in soft tissue deficiencies. Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Atrium Medical Corporation Aug-09-2013 C-QUR V-Patch Mesh – C-QUR V-Patch Mesh (All sizes and shapes).Intended for use in soft tissue deficiencies. Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Atrium Medical Corporation Aug-09-2013 C-QUR Edge Mesh – C-QUR Edge Mesh (All sizes and shapes).Intended for use in soft tissue deficiencies. Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Synthes USA HQ; Inc. Aug-09-2013 USS Small Stature – 5.0mm Unit steel rod; pedicle screw spinal system.Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received; and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t
GE Healthcare; LLC Aug-09-2013 GE LightSpeed CT750 HD Computed Tomography X-ray System – GE LightSpeed CT750 HDThe GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes; including Axial; Cine; Helical (Volumetric); Cardiac; Spectral; and Gated acquisitions for all ages. GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 – There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map; these artifacts will give subtle differences in the CT numbers.Event 2 – The software does no
Atrium Medical Corporation Aug-09-2013 C-QUR Mesh – C-QUR Mesh (All Sizes; shapes).Intended for use in soft tissue deficiencies. Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
GE Healthcare; LLC Aug-09-2013 Signa Infinity Signa Infinity Twinspeed Signa Vibrant Signa HDx Signa HDxt Signa HDxi – SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMGE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEMGE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa VibrantGE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEMThe GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution; high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse; sagittal; coronal and oblique images; spectroscopic images; and/or spectra; dynamic images of the internal structures and organs of the entire body; including but not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issuedue to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system; internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.
Veridex; LLC Aug-10-2013 CELLTRACKS AUTOPREP System – CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage:The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells; and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II; CellSpotter System; flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2; the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation. Veridex; LLC has received a report that a patient’s demographics were incorrectly associated with another patient’s identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.
Beckman Coulter Inc. Aug-10-2013 Synchron Systems LX20/ UniCel DxC ISE Reference Reagent – ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems); Part No. A28937; A28945; 467935; 467915.Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent; when used in conjunction with SYNCHRON LX System(s); UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1; 2 and 3; are intended for the quantitative determination of potassium concentration in human serum; plasma or urine. Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.
Veridex; LLC Aug-10-2013 CELLTRACKS ANALYZER II – CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage:The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells; and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II; CellSpotter System; flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1; the document states that the edit patient sample information screen now includes a patient information section; a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data. Veridex; LLC has received a report that a patient’s demographics were incorrectly associated with another patient’s identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.
Synthes USA HQ; Inc. Aug-12-2013 Synthes Flexible Medullary Reamer – Synthes Flexible Medullary Reamer.Intended to be used to facilitate the preparation of the intramedullary cavity. Due to the coiled design for this product; the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
Fisher Scientific Co Aug-12-2013 Fisherbrand Sterile Swabs – Fisherbrand Sterile Swab; Calcium Alginate Fiber Tipped; Wood Applicator Swab 100 pouches/boxes; 10 boxes/case.Used in applying medications to or take specimens from a patient. The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
Carestream Health Inc. Aug-12-2013 Carestream DRX Evolution System – Carestream DRX Evolution System; X-Ray System —The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Due to potential for an x-ray exposure technique change.
Zimmer; Inc. Aug-12-2013 Trabecular Metal – REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation; Glenosphere Helmet; 36 mm Diameter Nonsterile; Qty -1Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor. There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
Zimmer; Inc. Aug-12-2013 Trabecular Metal – REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation; Glenosphere Helmet; 40 mm Diameter Nonsterile; Qty -1Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor. There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
Medtronic Navigation; Inc. Aug-13-2013 STEALTHSTATION TREATMENT GUIDANCE PLATFORM – StealthStation S7 Framelink Software version 5.4.Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Medtronic Navigation; Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
Carefusion 2200 Inc Aug-13-2013 AirLife – 1) Adult Manual Resuscitator; 2K8004; Oxygen Reservoir Bag; Adult Mask; 2) Adult Manual Resuscitator; 2K8005; 40" (1.0 m) Oxygen Reservoir Tubing; Adult Mask; 3) Adult Manual Resuscitator; 2K8017; Variable Volume Oxygen Reservoir Tubing; Adult Mask; 4) Adult Manual Resuscitator; 2K8034; 40" (1.0 m) Oxygen Reservoir Tubing; PEEP Valve; without Mask; 5) Adult Manual Resuscitator; 2K8035; Oxygen Reservoir Bag; PEEP Valve; Adult Mask; 6) Pediatric Manual Resuscitator; 2K8037; 40" (1.0 m) Oxygen Reservoir Tubing; PEEP Valve; Pediatric Mask; Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator; 2K8040; Oxygen Reservoir Bag; PEEP Valve; Infant Mask; Pressure Limiting Valve with LockProduct Usage: Pulmonary resuscitation CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.
Biomet 3i; LLC Aug-13-2013 T3 Dental Implant – Biomet 3i Dental Implant; Parallel Walled 6mm (D) x 10mm (L) A small number of outer implant boxes may be mislabeled. The inner tray; containing the implant; is label correctly. This condition; if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
Biomet 3i; LLC Aug-13-2013 T3 Dental Implant – Biomet 3i Dental Implant; Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L) A small number of outer implant boxes may be mislabeled. The inner tray; containing the implant; is label correctly. This condition; if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
Vital Signs Devices; a GE Healthcare Company Aug-13-2013 General Purpose Temperature Probe – Disposable Temperature Probes; (sterile); Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company; 20 Campus Road; Totowa; NJ 07512 USA; www.gehealthcare.com/vitalsigns.Continuous temperature monitoring. GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe; Disposable; 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement; it has been brought to our attention that some users are inserting the probe
SpineFrontier; Inc. Aug-13-2013 Case/Caddy (tray; surgical; instrument) – Case Lid and Base (Inspan; Invue; SLIFT) Caddy Lid (Inspan; Arena-C); Inspan Lid: 12-60039A; 11-60042B; 11-60043B; 11-60045B; 11-60046C; 11-60045A; 11-60046A; 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D; 11-72014D; Generics Lid: 12-99005A.System cases are designed to hold and secure all instrumentation to be used with a surgical system. Non-toxic inks; used on the silk screen graphics of the case bases and lids; and caddy lids; were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
SpineFrontier; Inc. Aug-13-2013 Tipped Tapered Solid Driver (Screwdriver) – Invue Solid Driver; Tipped; AO. Part Number: 11-70083.Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Terumo Cardiovascular Systems Corporation Aug-14-2013 Terumo Advanced Perfusion System 1 – Terumo¿ Advanced Perfusion System 1: 100/120V AC; Advanced Perfusion System 1The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment. The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically; if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response; the labeling in the operators manual does not fully describe how th
Terumo Cardiovascular Systems Corporation Aug-14-2013 Terumo Advanced Perfusion System 1 – Terumo¿ Advanced Perfusion System 1: 220/240V AC; Advanced Perfusion System 1The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment. The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically; if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response; the labeling in the operators manual does not fully describe how th
Edwards Lifesciences; LLC Aug-14-2013 Anastaflo Intravascular Shunt – Edwards Lifesciences Anastaflo Intravascular Shunt; Model code IVS12512; IVS1512; IVS17512; IVS2012; IVS2512; IVS3012; IVS1530; IVS2030 and IVS25Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30. Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.
Arrow International Inc Aug-14-2013 Arrow Two-Lumen CVC Kit with Blue Flex Tip Catheter – Arrow International; Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients. Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Epocal Aug-14-2013 epoc BGEM Test Card – epoc BGEM Test Card (Catalogue number CT-1004-00-00).quantitative testing of samples for pH; pCO2; pO2; Sodium Potassium ; Ionized Calcium; Glucose; Lactate and Hematocrit. This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically; after a period of storage of three (3) to four (4) months; the Glucose sensor may report low results at the high end of the measurement range.
Medtronic Inc. Cardiac Rhythm Disease Management Aug-14-2013 Affinity Pediatric Arterial Filter; – Medtronic Affinity Pediatric Arterial Filter; model number S4014; sterilized using ethylene oxide. The Affinity Pediatric Arterial Filters are single-use; sterile; nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface. Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device; which could result in serious injury to a pediatric patient including neurological damage; or potential patient death.
Edwards Lifesciences; LLC Aug-14-2013 Edwards EndoReturn Arterial Cannula; model ER21B and ER23B – Edwards EndoReturn Arterial Cannula; model ER21B and ER23BProduct Usage:The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve); an introducer; a guidewire;and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve; an introducer; and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility; tapered tips to aid in insertion and advancement into the femoral artery; a non-reinforced clamp site; a 3/8 in. (9.5 mm) barbed connector; and a hemostasis valve (available on some versions) that allows passage of catheters; such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions; a connector hub secures and immobilizes the introducer within the cannula for easier; one person insertion of the cannula/introducer assembly. Edwards Lifesciences is recalling certain lots of theEndoReturn Arterial Cannula that were built with an incorrect component. This component can create aperformance problem with the IntraClude IntraAortic Occlusion device.
Terumo Cardiovascular Systems Corporation Aug-14-2013 Terumo¿ Advanced Perfusion System 1 – Terumo¿ Advanced Perfusion System 1 (APS1; System 1)100/120V ACProduct Usage:The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced PerfusionSystem 1 (APS1) Centrifugal Pump ‘Service Pump’ message may occur due to user inducedmotor movement. In this instance; the APS1 will identify the movement (as it isdesigned) and display a Service Pump message error. The user might interpret this as apump which requires service rather than a message displayed d
Terumo Cardiovascular Systems Corporation Aug-14-2013 Terumo¿ Advanced Perfusion System 1 – Terumo¿ Advanced Perfusion System 1 (APS1; System 1)Description: 220/240V ACProduct Usage:The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced PerfusionSystem 1 (APS1) Centrifugal Pump ‘Service Pump’ message may occur due to user inducedmotor movement. In this instance; the APS1 will identify the movement (as it isdesigned) and display a Service Pump message error. The user might interpret this as apump which requires service rather than a message displayed d
Terumo Cardiovascular Systems Corporation Aug-15-2013 Terumo Advanced PErfusion System 1 – 100/120V AC; Advanced Perfusion System 1Product Usage:The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump; this pressure display can be cleared and the pump re-started by disconnecting the pressure transduce
Terumo Cardiovascular Systems Corporation Aug-15-2013 Terumo Advanced PErfusion System 1 – 220/240V AC; Advanced Perfusion System 1Product Usage:The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump; this pressure display can be cleared and the pump re-started by disconnecting the pressure transduce
Siemens Medical Solutions USA; Inc Aug-15-2013 Siemens syngo.plaza – Siemens syngo.plaza SW version VA20 with Mammography license.image processing; radiological system Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances; it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
Boston Scientific CRM Corp Aug-16-2013 ENERGEN DR ICD – Boston Scientific; ENERGEN DR ICD; Model E143. The device is an Implantable Cardioverter Defibrillator. Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements; they showed a slightly longer charge time than other devices during a manufactu
Invacare Corporation Aug-17-2013 CHAMPION Medical Recliner; AC Powered with heat and massage – CHAMPION Medical Recliner; AC Powered with heat and massage; one chair per carton; or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery. There is a possibility of elevated temperatures in the seat pad. In addition; the hospital cord set does not agree with the labeling (information in manual).
Endogastric Solutions Inc Aug-17-2013 EndoGastric Solutions EsophyX2 Device – EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002.Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. Endogastric Solutions; Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case; surgical intervention was necessary to remove the device.
Zimmer; Inc. Aug-17-2013 Moore Hip Prosthesis Long Fenestrated Stem – Moore Hip Prosthesis Long Fenestrated Stem; several head Diameter; 203 mm Stem length.Used to seat the prosthesis with or without bone cement. Zimmer recently conducted a review of historic packaging validations completed. Based on this review; it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration; which
Gyrus Medical; Inc Aug-19-2013 GYRUS ACMI; REF 3740; Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm; Sterile EO – GYRUS ACMI; REF 3740; Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm; Sterile EO.GYRUS ACMI; REF 3740PK; or REF 94201PK; PKS LYONS; Dissecting Forceps 5mm/45cm; Sterile EO.The Dissectors are sterile; single use electrosurgical devices that are indicated for the electrosurgical coagulation; mechanical grasping; and dissection of tissue during the performance of laparoscopic and general surgical procedures. On April 29; 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
Aspen Surgical Products; Inc. Aug-20-2013 "Wound Closure Strips – Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure; Latex Free Sterile EO Rx; 1/4"" X 4 ""; 6 mm X100 mm; (2 Cards/pouch; 1;000 Pouches/box); Distributed in Europe: "" Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4"" X 4 ""; Sterile; Box 1000 pouches 5 strips /pouch; Pouch ; 5 strips 6 mm X100 mm Sterile EOProduct Number: 40-2893: Wound Closure Strips ; Sterile (1;000pouches/box)Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm; 1/4"" X 4 ""; RxProduct Usage: intended for skin closure and closure support for sutures and staples" Aspen Surgical is recalling Wound Closures because firm could not confirm sterility; after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.
GE Healthcare; LLC Aug-20-2013 Precision 500D – GE Healthcare; Precision 500DProduct Usage:The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and
GE Healthcare; LLC Aug-20-2013 Discovery NM/CT 570 c – The Discovery NM/CT 570c CT Standalone ScanThe Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications; head and body CT diagnostic imaging applications; as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries; the NM Gantry; carrying solid state Cadmium Zinc Telluride (CZT) detectors; the CT Gantry; a single patient table; power distribution unit (PDU); NMV integrated power supply (IPS) ; two operator consoles with two acquisition systems (Nuclear and CT); interconnecting cables and associated accessories (ECG gating; etc.). GE Healthcare has recently become aware of an incident where the wrong part of the patient body wasscanned during a CT standalone exam with the Discovery NM/CT 570c
Medtronic MiniMed Aug-20-2013 Medtronic MiniMed Paradigm Reservoirs – Medtronic MiniMed Paradigm Reservoirs; Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL)The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result; maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically; the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669;672 units Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition; if there is a leaky reservoir and an insulin blockage occurs in the infusion set; the pump may not
Atrium Medical Corporation Aug-20-2013 PleuraGuide Kit – PleuraGuide Disposable Chest Tube Kit; Product codes: 17100; 17150; and 17200.Indicated to assist with the insertion of thoracic catheters. Individual component’s IFUs are not included with the kit.
Sorin Group USA; Inc. Aug-20-2013 Edwards Lifesciences Suction Wand Model S099B – Edwards Lifesciences Suction Wand Model S099B; packaged in Sorin Group Heart/Lung Perfusion Packs. Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
Medicel Ag Aug-20-2013 nanoPOINT Injector System – Product Name: nanoPOINT Injector System; item number 37-0000-08.Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs; through surgical procedure in a human eye. The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and; therefore; the stability of the sterile barrier might be negatively affected.
Blue Belt Technologies MN Aug-21-2013 Blue Belt Technologies – Blue Belt Technologies; Inc. Monitor Drape REF: PFSD-V0001; Rx only; Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting. Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at
Stryker Communications Aug-21-2013 Stryker Visum 300 – Stryker Visum 300 Ceiling-mounted Exam Light. Potential incomplete final weld on the drop tube flange.
Getinge USA Inc Aug-21-2013 Getinge Assure – Getinge Assure Accufast Biological Indicators; Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack); STEAM — Manufactured for: Getinge USA; Inc. 1777 E. Henrietta Rd.; Rochester; NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C; 132¿C; 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation; the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam; distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization. AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
Philips Healthcare Inc. Aug-21-2013 MobileDiagnost wDR – Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray SystemProduct Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull; spinal column; chest; abdomen; extremities; and other body parts. Applications can be performed with patient sitting; standing; or lying in the prone or supine positions. Not intended for mammography. The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Smith & Nephew Inc Aug-22-2013 GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT; TRIAL – GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT; TRIAL; SIZE 3-4; A/P 48 MM; M/L 68 MM; QTY 1; NON-STERILE; REF 71430490; Product Usage:Orthopedic The products were produced using the wrong color material; resulting in the devicesbeing red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Beckman Coulter Inc. Aug-22-2013 Hemoccult ICT Test Hemoccult ICT (Immunochemical Fecal Occult Blood Test – Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid; visually read; qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Beckman Coulter has received a customer complaint that suggests trending ofpositive results has increased from approximately 4% to 1 0%. As a result of ourinvestigation; Beckman Coulter has confirmed an increase in sensitivity at theborderline positive level." This testing also demonstrated that the issue does not affect results reported asnegative.
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx; Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx; Sterile;65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx; Sterile;65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx; Sterile;00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx; Sterile;00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx; Sterile;00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 65597201101 Femur CR POR FEM HATCP SIZE AML Rx; Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx; Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx; Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx; Sterile;00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595601201 Femur CR-FLEX OPT FEM B-LRx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-RRx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595001201 Femur CR-FLEX PCT FEM B-L Rx; Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595201201 Femur CR-FLEX POR FEM B-LRx; Sterile;00595201202 Femur CR-FLEX POR FEM B-RRx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 65595201201 Femur CR-FLEX POR HATCP FEM B-LRx; Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-RRx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597001303 Femur CR PRC FEM COMP SIZE CML Rx; Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx; Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx; Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx; Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx; Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx; Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx; Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx; Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx; Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx; Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597201303 Femur CR POR FM COMP SIZE CML Rx; Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx; Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx; Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx; Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx; Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597201333 Femur CR POR SURF HDN FEM CO-NID CML; Rx; Sterile;00597201334 Femur CR POR SURF HDN FEM CO-NID CMR; Rx; Sterile;00597201433 Femur CR POR SURF HDN FEM CO-NID DML; Rx; Sterile;00597201434 Femur CR POR SURF HDN FEM CO-NID DMR; Rx; Sterile;00597201533 Femur CR POR SURF HDN FEM CO-NID EML; Rx; Sterile;00597201534 Femur CR POR SURF HDN FEM CO-NID EMR; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 65597201333 Femur CR POR FEM SURF HDN HATCP CML; Rx; Sterile;65597201334 Femur CR POR FEM SURF HDN HATCP CMR; Rx; Sterile;65597201433 Femur CR POR FEM SURF HDN HATCP DML; Rx; Sterile;65597201434 Femur CR POR FEM SURF HDN HATCP DMR; Rx; Sterile;65597201533 Femur CR POR FEM SURF HDN HATCP EML; Rx; Sterile;65597201534 Femur CR POR FEM SURF HDN HATCP EMR; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00587806126 Patella MICRO POROUS PAT 26MM X 10MM; Rx; Sterile;00587806129 Patella MICRO POROUS PAT 29MM X 10MM; Rx; Sterile;00587806132 Patella MICRO POROUS PAT 32MM X 10MM; Rx; Sterile;00587806135 Patella MICRO POROUS PAT 35MM X 10MM; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA; Rx; Sterile;00597206129 Patella ALL POLY PAT COMP MICRO 29DIA; Rx; Sterile;00597206132 Patella ALL POLY PAT COMP MICRO 32DIA; Rx; Sterile;00597206135 Patella ALL POLY PAT COMP MICRO 35DIA; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595202010 Articular Surface XLPE CR ART SURF 1;2/PUR 10; Rx; Sterile;00595202012 Articular Surface XLPE CR ART SURF 1;2/PUR 12; Rx; Sterile;00595202014 Articular Surface XLPE CR ART SURF 1;2/PUR 14; Rx; Sterile;00595202017 Articular Surface XLPE CR ART SURF 1;2/PUR 17; Rx; Sterile;00595202020 Articular Surface XLPE CR ART SURF 1;2/PUR 20; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17; Rx; Sterile;90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597002009 Articular Surface CR ART SURF 12/PURPLE 9; Rx; Sterile;00597002010 Articular Surface CR ART SURF 12/PURPLE 10; Rx; Sterile;00597002012 Articular Surface CR ART SURF 12/PURPLE 12; Rx; Sterile;00597002014 Articular Surface CR ART SURF 12/PURPLE 14; Rx; Sterile;00597002017 Articular Surface CR ART SURF 12/PURPLE 17; Rx; Sterile;00597002020 Articular Surface CR ART SURF 12/PURPLE 20; Rx; Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM; Rx; Sterile;90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM; Rx; Sterile;90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM; Rx; Sterile;90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM; Rx; Sterile;90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM; Rx; Sterile;90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597202009 Articular Surface CR ART SURF 12/PURPLE 09; Rx; Sterile;00597202010 Articular Surface CR ART SURF 12/PURPLE 10; Rx; Sterile;00597202012 Articular Surface CR ART SURF 12/PURPLE 12; Rx; Sterile;00597202014 Articular Surface CR ART SURF 12/PURPLE 14; Rx; Sterile;00597202017 Articular Surface CR ART SURF 12/PURPLE 17; Rx; Sterile;00597202020 Articular Surface CR ART SURF 12/PURPLE 20; Rx; Sterile;00597202023 Articular Surface CR ART SURF 12/PURPLE 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597602010 Articular Surface AC ART SURF 12/PUR 10; Rx; Sterile;00597602012 Articular Surface AC ART SURF 12/PUR 12; Rx; Sterile;00597602014 Articular Surface AC ART SURF 12/PUR 14; Rx; Sterile;00597602017 Articular Surface AC ART SURF 12/PUR 17; Rx; Sterile;00597602020 Articular Surface AC ART SURF 12/PUR 20; Rx; Sterile;00597602023 Articular Surface AC ART SURF 12/PUR 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595203110 Articular Surface XLPE CR ART SURF 3;4/SYEL 10; Rx; Sterile;00595203112 Articular Surface XLPE CR ART SURF 3;4/SYEL 12; Rx; Sterile;00595203114 Articular Surface XLPE CR ART SURF 3;4/SYEL 14; Rx; Sterile;00595203117 Articular Surface XLPE CR ART SURF 3;4/SYEL 17; Rx; Sterile;00595203120 Articular Surface XLPE CR ART SURF 3;4/SYEL 20; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17; Rx; Sterile;90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9; Rx; Sterile;00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10; Rx; Sterile;00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12; Rx; Sterile;00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14; Rx; Sterile;00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17; Rx; Sterile;00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20; Rx; Sterile;00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM; Rx; Sterile;90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM; Rx; Sterile;90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM; Rx; Sterile;90597003114 Articular Surface CR ART SURF 34/STR YEL 14MM; Rx; Sterile;90597003117 Articular Surface CR ART SURF 34/STR YEL 17MM; Rx; Sterile;90597003120 Articular Surface CR ART SURF 34/STR YEL 20MM; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09; Rx; Sterile;00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10; Rx; Sterile;00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12; Rx; Sterile;00597203114 Articular Surface CR ART SURF 34/STRIPE YEL 14; Rx; Sterile;00597203117 Articular Surface CR ART SURF 34/STRIPE YEL 17; Rx; Sterile;00597203120 Articular Surface CR ART SURF 34/STRIPE YEL 20; Rx; Sterile;00597203123 Articular Surface CR ART SURF 34/STRIPE YEL 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10; Rx; Sterile;00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12; Rx; Sterile;00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10; Rx; Sterile;00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10; Rx; Sterile;00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10; Rx; Sterile;00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10; Rx; Sterile;00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12; Rx; Sterile;00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14; Rx; Sterile;00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17; Rx; Sterile;00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17; Rx; Sterile;90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9; Rx; Sterile;00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10; Rx; Sterile;00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12; Rx; Sterile;00597004114 Articular Surface CR ART SURF 56/STRIPE GREEN 14; Rx; Sterile;00597004117 Articular Surface CR ART SURF 56/STRIPE GREEN 17; Rx; Sterile;00597004120 Articular Surface CR ART SURF 56/STRIPE GREEN 20; Rx; Sterile;00597004123 Articular Surface CR ART SURF 56/STRIPE GREEN 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM; Rx; Sterile;90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM; Rx; Sterile;90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM; Rx; Sterile;90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM; Rx; Sterile;90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM; Rx; Sterile;90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9; Rx; Sterile;00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10; Rx; Sterile;00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12; Rx; Sterile;00597204114 Articular Surface CR ART SURF 56/STRIPE GRN 14; Rx; Sterile;00597204117 Articular Surface CR ART SURF 56/STRIPE GRN 17; Rx; Sterile;00597204120 Articular Surface CR ART SURF 56/STRIPE GRN 20; Rx; Sterile;00597204123 Articular Surface CR ART SURF 56/STRIPE GRN 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10; Rx; Sterile;00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12; Rx; Sterile;00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14; Rx; Sterile;00597604117 Articular Surface AC ART SURF 56/STRIPED GRN 17; Rx; Sterile;00597604120 Articular Surface AC ART SURF 56/STRIPED GRN 20; Rx; Sterile;00597604123 Articular Surface AC ART SURF 56/STRIPED GRN 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597101101 Provisional CR PROV FRM COMP SIZE AML; Rx; Sterile;00597101102 Provisional CR PROV FRM COMP SIZE AMR; Rx; Sterile;00597101201 Provisional CR PROV FRM COMP SIZE BML; Rx; Sterile;00597101202 Provisional CR PROV FRM COMP SIZE BMR; Rx; Sterile;00597101303 Provisional CR PROV FRM COMP SIZE CML; Rx; Sterile;00597101304 Provisional CR PROV FRM COMP SIZE CMR; Rx; Sterile;00597101403 Provisional CR PROV FRM COMP SIZE DML; Rx; Sterile;00597101404 Provisional CR PROV FRM COMP SIZE DMR; Rx; Sterile;00597101503 Provisional CR PROV FRM COMP SIZE EML; Rx; Sterile;00597101504 Provisional CR PROV FRM COMP SIZE EMR; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00595501201 Provisional CR-FLEX FEM PROV SZ B-L; Rx; Sterile;00595501202 Provisional CR-FLEX FEM PROV SZ B-R; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML; Rx; Sterile;00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26; Rx; Sterile;00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29; Rx; Sterile;00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32; Rx; Sterile;00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM; Rx; Sterile;00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM; Rx; Sterile;00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM; Rx; Sterile;00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597502010 Provisional AC ART SURF PROV 12/PUR 10; Rx; Sterile;00597502012 Provisional AC ART SURF PROV 12/PUR 12; Rx; Sterile;00597502014 Provisional AC ART SURF PROV 12/PUR 14; Rx; Sterile;00597502017 Provisional AC ART SURF PROV 12/PUR 17; Rx; Sterile;00597502020 Provisional AC ART SURF PROV 12/PUR 20; Rx; Sterile;00597502023 Provisional AC ART SURF PROV 12/PUR 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10; Rx; Sterile;00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12; Rx; Sterile;00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14; Rx; Sterile;00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17; Rx; Sterile;00597503120 Provisional AC ARTSURF PROV 34/STRIPE YEL 20; Rx; Sterile;00597503123 Provisional AC ARTSURF PROV 34/STRIPE YEL 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10; Rx; Sterile;00597504112 Provisional AC ART SURF PROV 56/STR GRN 12; Rx; Sterile;00597504114 Provisional AC ART SURF PROV 56/STR GRN 14; Rx; Sterile;00597504117 Provisional AC ART SURF PROV 56/STR GRN 17; Rx; Sterile;00597504120 Provisional AC ART SURF PROV 56/STR GRN 20; Rx; Sterile;00597504123 Provisional AC ART SURF PROV 56/STR GRN 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10; Rx; Sterile;00597102012 Provisional CR ART SURF PROV 12/PURPLE 12; Rx; Sterile;00597102014 Provisional CR ART SURF PROV 12/PURPLE 14; Rx; Sterile;00597102017 Provisional CR ART SURF PROV 12/PURPLE 17; Rx; Sterile;00597102020 Provisional CR ART SURF PROV 12/PURPLE 20; Rx; Sterile;00597102023 Provisional CR ART SURF PROV 12/PURPLE 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10; Rx; Sterile;00597103112 Provisional CR ART SURF PROV 34/STR YEL 12; Rx; Sterile;00597103114 Provisional CR ART SURF PROV 34/STR YEL 14; Rx; Sterile;00597103117 Provisional CR ART SURF PROV 34/STR YEL 17; Rx; Sterile;00597103120 Provisional CR ART SURF PROV 34/STR YEL 20; Rx; Sterile;00597103123 Provisional CR ART SURF PROV 34/STR YEL 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10; Rx; Sterile;00597104112 Provisional CR ART SURF PROV 56/STR GRN 12; Rx; Sterile;00597104114 Provisional CR ART SURF PROV 56/STR GRN 14; Rx; Sterile;00597104117 Provisional CR ART SURF PROV 56/STR GRN 17; Rx; Sterile;00597104120 Provisional CR ART SURF PROV 56/STR GRN 20; Rx; Sterile;00597104123 Provisional CR ART SURF PROV 56/STR GRN 23; Rx; Sterile;Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 "NexGen Complete Knee Solution – 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx; Sterile;00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx; Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx; Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain." Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 Nex Gen Complete Knee Solution – 00597001101 Femur CR PRECOAT FEM COMP SIZE AML; Rx; Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR; Rx; Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML; Rx; Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR; Rx; Sterile.Used in total knee arthroplasty and indicated for patients with severe pain. Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Zimmer; Inc. Aug-22-2013 NexGen Complete Knee Solution – 00597001131 Femur CR PRC SURF HDN FEM CO-NID AML; Rx; Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR; Rx; Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML; Rx; Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR; Rx; Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs; CR Micro Articular Surface; CR Micro Patellae; CR Micro instruments and provisionals combined with standard components. Alth
Nidek Inc Aug-23-2013 NAVIS-EX – NAVIS-EX ; Image Filing Software for NIDEK AFC Fundus camera; Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Under certain circumstances; the Left eye image may be saved as the Right eye image.
Siemens Healthcare Diagnostics Aug-23-2013 IMMULITE – PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers; Catalog Numbers LKPS1; LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers; Catalog Numbers L2KPS2; L2KPS6; L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100; 200; 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374.Product Usage:For the quantitative measurement of prostate-specific antigen (PSA) in human serum; as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias i
Micro Therapeutics Inc; Dba Ev3 Neurovascular Aug-23-2013 Pipeline Embolization Device – Pipeline Embolization Device (PED)The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally; the designation of aspirin and clopidogrel was missing from the following contraindication "
Sarken; Inc. Aug-23-2013 SARKEN STAT! 1- Panel Test Kit-mAMP – SARKEN STAT! 1- Panel Test Kit-mAMPProduct Usage:Labeled as FOR FORENSIC USE ONLY (Employee; Student or Probation Testing). These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Sarken; Inc. Aug-23-2013 SARKEN STAT! 1- Panel Test Kit-OPI – SARKEN STAT! 1- Panel Test Kit-OPIProduct Usage: Labeled as FOR FORENSIC USE ONLY (Employee; Student or Probation Testing). These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Sarken; Inc. Aug-23-2013 SARKEN STAT! 1- Panel Test Kit-COC – SARKEN STAT! 1- Panel Test Kit-COCProduct Usage- Labeled as FOR FORENSIC USE ONLY (Employee; Student or Probation Testing). These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Sarken; Inc. Aug-23-2013 SARKEN STAT! Multi-Drug Test Panel – SARKEN STAT! Multi-Drug Test PanelProduct Usage- Labeled as FOR FORENSIC USE ONLY (Employee; Student or Probation Testing). These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Sarken; Inc. Aug-23-2013 SARKEN STAT! Multi-Drug Test Panel – SARKEN STAT! Multi-Drug Test PanelProduct Usage- Labeled as FOR FORENSIC USE ONLY (Employee; Student or Probation Testing). These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Sarken; Inc. Aug-23-2013 SARKEN STAT! 1- Panel Test Kit-THC – SARKEN STAT! 1- Panel Test Kit-THCProduct Usage- Labeled as FOR FORENSIC USE ONLY (Employee; Student or Probation Testing). These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Siemens Medical Solutions USA; Inc Aug-26-2013 PRIMUS; ONCOR; ARTISTE Linac systems – PRIMUS; ONCOR; ARTISTE Linac systems with component Tabletop; 550TxT; TT-A s/n 1001-1233 and Tabletop 550TxT; TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded; ARTISTE; ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error; the screws holding the side rails in position on the tabletop might break off.
Zimmer; Inc. Aug-26-2013 Trabecular Metal – 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx; Non sterile (sterilize before use)The Glenosphere Distractor must be able to attach; connect; or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid; or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate. Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result; there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition; there is a potential for the foot of the device to fract
Philips Healthcare Inc. Aug-26-2013 Radiographic system; digital – Philips Easy Upgrade DR; Code No: 712086This system is used for making X-Ray exposures for diagnostics. The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
Stryker Craniomaxillofacial Division Aug-26-2013 Hydroset – Stryker Part Numbers 79-43903 (3cc); 79-43905 (5cc); 79-43910 (10 cc); 79-43915 (15cc); 397003 (3cc); 397005 (5cc); 397010 (10 cc); 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO; nonpyrogenic; Product of IrelandStryker Injectable Cement is a self-setting; calcium phosphate cement intended for use in the repair of neurosurgical burr holes; contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation. Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery.
MCKESSON TECHNOLOGIES INC Aug-26-2013 Mc Kesson Anesthesia-Rx – Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispenseProduct Usage: Automated anesthesia cart that monitors and controls the dispensing of medications; narcotics and supplies during surgical procedures. The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use.
Fresenius Medical Care Holdings; Inc. dba Renal Solutions Aug-26-2013 2008 MeDS Pump; Venofer(R) Pump – 2008 MeDS Pump; Venofer(R) PumpProduct Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis; where Venofer; in conjunction with hemodialysis; is prescribed by a physician. Product is being recalled because the combination of the current 50 mg vial; the 2008 MeDS pump; and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall
Synthes USA HQ; Inc. Aug-26-2013 Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right – Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/RightProduct Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones. The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
Synthes USA HQ; Inc. Aug-26-2013 Synthes Trauma Nail System – Synthes Trauma Nail System. The devices are indication for bone fixation. Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile; internal pouch within an external pouch. It is the outer; external pouch that may be compromised.
Siemens Healthcare Diagnostics; Inc. Aug-26-2013 Dimension Vista Intelligent Lab Systems – Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting; mixing; heating; and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric; turbidimetric; chemiluminescence; nephelometric; and integrated ion-selective multisensory technology for clinical use. Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset; there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot
Brainlab AG Aug-26-2013 43410 FRAMELESS SRS QA TARGET POINTER – BRAINLAB; FRAMELESS SRS QA TARGET POINTERRobotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation; localization and repositioning of the patient’s: head and neck; and head; neck; and shoulders; in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures. The Frameless SRS QA Target Pointer – Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
Synthes USA HQ; Inc. Aug-26-2013 Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting Attachment; 1.2Nm – Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment; 1.2NmSynthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/25; Stem size 06; prox. Stem dia. 25 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/12; Stem size S-0; prox. Stem dia. 12 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/14; Stem size S-1; prox. Stem dia. 14 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/16; Stem size S-2; prox. Stem dia. 16 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/18; Stem size S-3; prox. Stem dia. 18 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/20; Stem size S-4; prox. Stem dia. 20 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/22; Stem size S-5; prox. Stem dia. 22.5 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0155/25; Stem size S-6; prox. Stem dia. 25 mm; Length 180 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Integra Limited Aug-26-2013 Integra Leyla Ball Joint Clamp – Integra Leyla Ball Joint Clamp; also as included in Leyla Table Mounting Hardware. The Leyla Retraction System; as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery. As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/25; Stem size 006; prox. Stem dia. 25 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/22; Stem size 005; prox. Stem dia. 22.5 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/20; Stem size 004; prox. Stem dia. 20 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/18; Stem size 003; prox. Stem dia. 18 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/16; Stem size 002; prox. Stem dia. 16 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/14; Stem size 001; prox. Stem dia. 14 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0142/12; Stem size 00; prox. Stem dia. 12 mm; Length 210 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/22; Stem size 05; prox. Stem dia. 22.5 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/20; Stem size 04; prox. Stem dia. 20 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/18; Stem size 03; prox. Stem dia. 18 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/12; Stem size 0; prox. Stem dia. 12 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/14; Stem size 01; prox. Stem dia. 14 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.) Aug-26-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS – TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS; REF 99-0143/16; Stem size 02; prox. Stem dia. 16 mm; Length 250 mm; WALDEMAR LINK GmbH & CoKG; Barkhausenweg 10 . D . 22339 Hamburg The trial stems were manufactured using the wrong design.
Zimmer; Inc. Aug-26-2013 Free Lock Femoral Fixation System – Free Lock Femoral Hip Fixation System Compression Tube/Plate; different length (59; 75; 91; 107; 123 mm); holes (2; 3; 4; 5; 6) and degree angles (130; 135; 140; 145 and 150). Item codes starting with 00-1181-130; 00-1181-135; 00-1181-140; 00-1181-145; 00-1181-150). ZIMMER Compression Hip Screw ; orthopedic implant. Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Zimmer; Inc. Aug-26-2013 Free Lock Femoral Fixation System – VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE; standard and short low profiles; several holes/length combinations (2/54; 3/70; 4/86; 5/102; 6/118) and several angles (130; 135; 140; 145 and 150). Item codes starting with 00-1193-130; 00-1193-135; 00-1193-140; 00-1193-145; 00-1193-150. orthopedic implant. Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Zimmer; Inc. Aug-26-2013 Free Lock Femoral Fixation System – VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE; standard and short – low profile; different hole/length combinations (4/86; 5/102 and 6/118); different degree angles (130; 135; 140; 145 and 150). Item codes starting with 00-194-130; 00-1194-135; 00-1194-140; 00-1194-145; 00-1194-150).; orthopedic implant. Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Life Technologies Corporation Aug-26-2013 HSV-2 Primers – HSV 2 Primers; Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests. Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
Zimmer; Inc. Aug-26-2013 Free Lock Femoral Fixation System – Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05; 00-1181-10 and 00-1181-15.ZIMMER Compression Hip Screw; orthopedic implant. Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Zimmer; Inc. Aug-26-2013 Free Lock Femoral Fixation System – VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW; several length (55 mm to 155 mm); diameters (12.7 mm and 15.8 mm) and short thread; standard thread and large thread. Item codes starting with 00-1193-005; 00-1193-010 and 00-1193-015.orthopedic implant. Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Respironics California Inc Aug-26-2013 Esprit Ventilator – Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics; Model No. V1000 The power to the Esprit Display’s Backlight is interrupted; causing the GUI to flicker or go dark and making the display unreadable.
GE Healthcare; LLC Aug-27-2013 GE Ultrasound ViewPoint 6 – GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images; electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images; drawings; and charts into medical reports. ViewPoint is designed to accept; transfer; display; calculate; store and process medical images and data; and enables the user to measure and annotate the images. The medical images; which ViewPoint displays to the user; can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system. GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13; 18; and 21;
Medtronic Inc. Cardiac Rhythm Disease Management Aug-27-2013 Medtronic Custom Perfusion System – Medtronic Custom Perfusion System. Model Numbers: 1D80R8; 1E34R1; 1F75R1; 1G49R2; 1G75R1; 1P07R8; 1P91R4; 5B15R11; and 5P51R9. Sterilized by Ethylene Oxide; Do no Reuse. Product Usage:This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand; model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
Medtronic Inc. Cardiac Rhythm Disease Management Aug-27-2013 Medtronic Custom Perfusion System – Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide; Do no Reuse. Product Usage: Usage:This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand; model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
Zimmer; Inc. Aug-27-2013 Zimmer Periarticular Locking Plate System; Distal Medial Humeral Locking Plate; Short – ZIMMER PERIARTICULAR LOCKING PLATE SYSTEMDISTAL MEDIAL HUMERAL LOCKING PLATE; SHORTRIGHT 11 HOLES 178 MM LENGTHSTERILE RX ONLYProduct Usage: Usage:The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures; including: Comminuted fractures; supracondylar fractures; intra-articular and extra-articular condylar fractures; fractures in osteopenic bone; nonunions; and malunions. Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate; Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided; but the Chinese label indicates that the implants are LEFT sided.
Medtronic Inc. Cardiac Rhythm Disease Management Aug-27-2013 Medtronic Custom Perfusion System with Trillium BioSurface – Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8; TL5D01R; TL5D02R; TL5D02R3; TL5D02R5; and TL6A65R7. Sterilized by Ethylene Oxide; Do no Reuse. Product Usage: Usage:This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand; model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
3M Company/3m Espe Dental Products Aug-27-2013 3M ESPE Unitek Primary Stainless Steel Crowns – 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4); Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box).Product Usage:Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth. 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
Megadyne Medical Products; Inc. Aug-27-2013 E-Z Clean¿ Disposable Laparoscopic Electrode – E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ – polyester peel pouch; 6 pouches per box.The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. Megadyne Medical Products is recalling certain lots of E-Z Clean; L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.
SpineNet Aug-27-2013 SpineNet Anterior Cervical Cage – SpineNet Anterior Cervical Cage; Lordotic; Peek (originally submitted as Daytona Anterior Cervical Cage)Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
SpineNet Aug-27-2013 SpineNet Bone Marrow Aspiration Needle Kit – SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M).Use to aspirate bone morrow. SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
Stryker Howmedica Osteonics Corp. Aug-27-2013 Asnis III Csnnulated Screw System – Stryker 1) Asnis III Cannulated Screw REF 6046404.0x40mm TL 13.5mm2) Asnis III Cannulated Screw REF 604642S4.0x42mm TL 14mm; sterileProduct Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use. Stryker received a report that the length of the cannulated screw asnis III; article # 604640 Lot R11482; was incorrect.
Alphatec Spine; Inc. Aug-27-2013 lllico Ti Cannulated Polyaxial Screw – Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants; due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver; the guide wire may not pass through the screwdriver.
DeRoyal Industries Inc Aug-28-2013 Insufflation Tubing Sets – DeRoyal Insufflation Tubing sets:1) REF 28-0206 Insufflation Tubing; Laparoscopic Rx Only2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing; Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing; Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only.Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen. DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.
Siemens Medical Solutions USA; Inc Aug-28-2013 Siemens Axiom Artis – Axiom Artis systems. C-arm angiographic x-ray systemx-ray; angiographic system. The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
Becton Dickinson & Co. Aug-28-2013 PrepStain Tecan US-I – PrepStain Tecan US-I.For use in the screening and detection of cervical cancer. PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Becton Dickinson & Co. Aug-28-2013 PrepStain AG – PrepStain AG.For use in the screening and detection of cervical cancer. PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
GE Healthcare; LLC Aug-28-2013 Dash 3000/4000/5000 Patient Monitor – GE Healthcare; Dash 3000; Dash 4000 and Dash 5000.Product Usage: The intended use of the system is to monitor physiologic parameter data on adult; pediatric and neonatal patients. GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH; PDM; and/or Tram Module. ECG and Respiration signal noise caused by DASH; PDM; and/or Tram ECG cable connector movement may result in reduced ECG; Respiration and arrhythmia detection performance.
GE Healthcare; LLC Aug-28-2013 Solar 8000 and Transport Pro with Patient Data Module (Marketed as CARESCAPE Patient Data Module) – SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE(Marketed As GE Healthcare CARESCAPE Patient Data Module)Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult; pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH; PDM; and/or Tram Module. ECG and Respiration signal noise caused by DASH; PDM; and/or Tram ECG cable connector movement may result in reduced ECG; Respiration and arrhythmia detection performance.
GE Healthcare; LLC Aug-28-2013 TRAM module – GE Healthcare; TRAM MODULE; High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult; pediatric and neonatal patients during transport from one area of the hospital or facility; and monitoring system; to another. GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH; PDM; and/or Tram Module. ECG and Respiration signal noise caused by DASH; PDM; and/or Tram ECG cable connector movement may result in reduced ECG; Respiration and arrhythmia detection performance.
Becton Dickinson & Co. Aug-28-2013 PrepStain Tecan US-II – PrepStain Tecan US-II.For use in the screening and detection of cervical cancer. PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Ventana Medical Systems Inc Aug-28-2013 Benchmark & Discovery – Benchmark XT/LT and Discovery XTModel Numbers: N750-BMK-FS; N750-BMKXT-FS; N750-BMKLT-FS; N750-DIS-FS; N750-DISXT-FS.Product Usage: Usage:The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality. Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally; the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
Siemens Healthcare Diagnostics Aug-28-2013 ADVIA 120 – ADVIA 120 Hematology Analyzer; Catalog Numbers SMN 10360958 and 10360959 .The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts. The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised; it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time; it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during m
Roche Diagnostics Operations; Inc. Aug-28-2013 ACCU-CHECK FastClix – ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system. Internal Roche inspections have revealed that after the lancet is used for a finger stick; the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.
Stryker Howmedica Osteonics Corp. Aug-29-2013 Stryker Orthopaedics – Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609); for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker’s Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument. Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp; an instrument.
