
Class I recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Mizuho Orthopedic Systems Inc | Oct-27-2011 | Modular Table System – Mizuho OSI Modular Table System;Product Usage: For use in orthopaedic surgery to provide support to a patient. | Reports of injury related incidents while using the Mizuho OSI Modular Table System. |
CareFusion 203; Inc. | Oct-26-2011 | EnVe Ventilator – CareFusion EnVe Ventilator; Model 19250-001. Manufactured by: CareFusion; 22745 Savi Ranch; Yorba Linda; CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable; a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). | CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions. |
Progressive Medical Inc | Oct-24-2011 | Medpro AccuFlo Elastomeric Infusion Device – Medpro AccuFlo Elastomeric Infusion Device; Model #CT-0020-270C; packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd.; Singapore.The devices are intended for patients requiring intravenous; percutaneous; subcutaneous; intra-operative sites or epidural administration of medications. | The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients. |
Victus; Inc. | Oct-24-2011 | Elastomeric Infusion Pump – "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360; Moo 6; Chonburi Industrial Estate; Tambon Bowin; Amphur Sriracha; Chonburi 20230; Thailand***Victus Inc. 4918 SW 74 Court 33155 44400***"Packed 24 units per case.The devices are intended for patients requiring intravenous; percutaneous; subcutaneous; intra-operative sites or epidural administration of medications. | Victus; Inc. Miami; FL is recalling Vipat Brand Elastomeric Infusion Pump; Model H0020-100; Lot 100533. The product may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to patients. |
B Braun Medical; Inc | Oct-18-2011 | Outlook ES Safety Infusion System – Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump); and provides clinically accepted volumetric accuracy for all standard IV fluids; including blood; lipid; and Total Parenteral Nutrition (TPN). Model number: 621-300ES; 621-400ES; 621-400ESR.To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. | B Braun Outlook ES Safety Infusion System "Run" Light Emitting Diodes (LEDs) pumps stop infusing and a backup alarm sounds; but the "Run" LEDs advance as if the pumps were infusing. |
CooperVision Inc. | Oct-14-2011 | AVAIRA – AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses; 6 SOFT CONTACT LENSES FOR ASTIGMATISM; CooperVision; Scottsville; NY 14546 USA; Juana Diaz; PR 00795 USA; Hamble SO31; 4RF; UK; Device Listing # D033736.Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single – use disposable wear and daily wear. When prescribed for frequent replacement; the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. | This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy or blurry vision and discomfort; most likely caused by transient or reversible swelling of the surface layer of the cornea; which is known as corneal epithelial edema. Corneal epithelial edema results |
Class II recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Baxter Healthcare Corp. | Oct-28-2011 | Baxter Flo-Gard 6301 Volumetric Infusion Pump – Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation; Deerfield; IL 60015; Product Code # 2M8064.The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates. | The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test. |
Sierra Scientific Instruments Inc | Oct-28-2011 | Sierra Scientific Motility Visualization System (MVS) – AR ManoShield; MSS-3599; 10 pack.FGS: MSS-3599;Individual package label: LBL-110275-03;Box label: LBL-110282-03;Package Inserts: DOC-3682;User Manual: DOC-1332-12.Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient. | The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test; the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting; a decision was made to voluntarily recall this product; and cease its further commercialization or distr |
Stryker Communications Corp | Oct-28-2011 | SwitchPoint Infinity Control System – SwitchPoint Infinity Control SystemStryker Communications; 1410 Lakeside Parkway; # 100; Flower Mound; TX 75208The SwitchPoint Infinity (SPI) Control System is an integrated voice; video; data router and teleconferencing interface for operating rooms. The SwitchPoint Infinity is used for direct control of room equipment; audio/video equipment; and indirect control of surgical equipment in the operating room. | Installation records for the SwitchPoint Infinity; Booms; Lights; and Flat Panel systems are incomplete or inadequate. |
Stryker Communications Corp | Oct-28-2011 | Visum LED Surgical Lights/ Visum Halogen Surgical Lights – Visum LED Surgical Lights/ Visum Halogen Surgical Lights.Stryker Communications; 1410 Lakeside Parkway; # 100; Flower Mound; TX 75208Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures. | Installation records for the SwitchPoint Infinity; Booms; Lights; and Flat Panel systems are incomplete or inadequate. |
Stryker Communications Corp | Oct-28-2011 | Stryker Equipment Delivery System (EDS) – Stryker Communications; 1410 Lakeside Parkway; # 100; Flower Mound; TX 75208Stryker EDS (Equipment Delivery System) Booms and Flat Panel Suspensions are intended for use as ceiling-mounted devices to support or position equipment; monitors; cameras or light heads and/or deliver gases and/or electricity to these equipments. They are available in articulating and non-articulating configurations; in single or tandem (pair) configuration; with different shelves configuration to allow various load capacities. | Installation records for the SwitchPoint Infinity; Booms; Lights; and Flat Panel systems are incomplete or inadequate. |
GE Healthcare; LLC | Oct-28-2011 | Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System – GE Healthcare; Innova¿ 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System.Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; diagnostic and interventional procedures; and optionally; rotational imaging-procedures. | A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails. |
Philips Healthcare Inc. | Oct-27-2011 | Philips BV Pulsera – Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095Product Usage: Fluoroscopic x-ray system; image-intensified Fluoroscopic x-ray system. | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
Invivo Corporation | Oct-27-2011 | Precess MRI Patient Monitoring System – Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B; 94044; 94045 (radio and radio kits).Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway; Orlando; FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando; FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS.The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. | Philips Invivo has determined that it is possible for the system’s alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermittent and frequent loss of communication between the wireless Processing Unit and the Display Controller Unit. |
Philips Healthcare Inc. | Oct-27-2011 | Philips BV Endura – Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system; image-intensified Fluoroscopic x-ray system. | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
Philips Healthcare Inc. | Oct-27-2011 | Philips Verardius – Philips Verardius Image Intensified X-ray Catalog Number: 718130Product Usage: Fluoroscopic x-ray system; image-intensified Fluoroscopic x-ray system. | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
Lifeline First Aid LLC | Oct-27-2011 | Highlands First Aid Kit – Highlands First Aid Kit; Part Number 4116; UPC 0-91966-04116-9; contains 65 Pieces. The kit is labeled in parts: "***HIGHLANDS FIRST AID KIT***MODEL 4166***1 IODINE PREP PADS***Lifeline First Aid; LLC***Wilsonville; OR 97070; USA***www.lifelinefirstaid.com***".First aid kit. | The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad. |
Lifeline First Aid LLC | Oct-27-2011 | ARC DISASTER KIT – ARC DISASTER KIT (American Red Cross); Part Number 7201; UPC 0-91966-04708-6; The kit is labeled in parts: "***American Red Cross***Item 7201***2 IODINE PREP PADS***Produced by the American Red Cross***Oregon Trail Chapter***503-528-5848***PO Box 3200; Portland; OR 97208***www.RedCross.org***".First aid kit. | The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad. |
Lifeline First Aid LLC | Oct-27-2011 | Mountain First Aid Kit – Mountain First Aid Kit; Part Number 4118; UPC 0-91966-04118-3; contains 88 Pieces. The kit is labeled in parts: "***MOUNTAIN FIRST AID KIT***MODEL 4118***1 IODINE PREP PADS***Lifeline First Aid; LLC***Wilsonville; OR 97070; USA***www.lifelinefirstaid.com***".First aid kit. | The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad. |
Lifeline First Aid LLC | Oct-27-2011 | Base Camp First Aid Kit – Base Camp First Aid Kit; Part Number 4150; UPC 0-91966-04150-3; contains 171 pieces.The kit is labeled in parts: "***BASE CAMP FIRST AID KIT***171 PIECE***6 IODINE PREP PADS***Lifeline First Aid; LLC***Wilsonville; OR 97070; USA***www.lifelinefirstaid.com***".First aid kit. | The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad. |
Lifeline First Aid LLC | Oct-27-2011 | Wilderness First Aid Kit – Wilderness First Aid Kit; Part Number 4120; UPC 0-91966-04120-6; contains 110 Pieces. The kit is labeled in parts: "***WILDERNESS FIRST AID KIT***MODEL 4120***2 IODINE PREP PADS***Lifeline First Aid; LLC***Wilsonville; OR 97070; USA***www.lifelinefirstaid.com***".First aid kit. | The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX7 – SYNCHRON CX7 Clinical System Part #: 756602Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX5 CE – SYNCHRON CX5 CE Clinical System Part #: 448700Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX5 Delta – SYNCHRON CX5 Delta Clinical System Part #: 468243Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX5 – SYNCHRON CX5 Clinical System Part #: 759300Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX9 Delta – SYNCHRON CX9 Delta ALX System Part #: 473513Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX4 CE – SYNCHRON CX4 CE Clinical System Part #: 756600Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX4 Delta – SYNCHRON CX4 Delta Clinical System Part #: 468233Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX4 – SYNCHRON CX4 Clinical System Part #: 758300Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
Beckman Coulter Inc. | Oct-27-2011 | SYNCHRON CX7 Delta – SYNCHRON CX7 Delta Clinical System Part #: 468205Product Usage: The Beckman SYNCHRON CX4 DELTA; CX7 DELTA; CX4CE; and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE; CX4/5/7 Delta and CX9 ALX Clinical Systems. |
GE Healthcare; LLC | Oct-26-2011 | GE Healthcare; MSK 1.5T Extreme MR Scanner Model AA5000 – GE HEALTHCARE; MSK 1.5T EXTREME MR SCANNER; MODEL AA5000.The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial; sagittal; coronal and oblique images of the internal structures of the leg (excluding the thigh); knee; ankle; foot; forearm; elbow; wrist and hand. | GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause electrical shock; which may impact service personnel safety. This issue does not impact patient or operator safety. |
Salter Laboratories; Division of Regulatory Affairs | Oct-26-2011 | Mask adult; elastic strap style; Percent-O2 Lock air entrainment system – Mask adult; elastic strap style; Percent-O2 Lock air entrainment system; w/7′ tube (Linde) – 50/cs;Salter Labs; Arvin; CA 93203Intended usage: respiratory therapy. | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
Salter Laboratories; Division of Regulatory Affairs | Oct-26-2011 | Mask adult; oxygen; medium concentration; elastic strap – Mask adult; oxygen; medium concentration; elastic strap style; w/9′ tube – 50/cs;Salter Labs; Arvin; CA 93203Intended usage: respiratory therapy. | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
Salter Laboratories; Division of Regulatory Affairs | Oct-26-2011 | Mask adult; oxygen; medium concentration; non-breathing – Mask adult; oxygen; high concentration; non-rebreathing; elastic strap style; w/9′ tube and safety vent – 50/cs;Mask adult; oxygen; high concentration; non-rebreathing; elastic strap style; w safety vent – 50/cs;Mask adult; oxygen; high concentration; non-rebreathing; elastic strap style; w/7′ tube and safety vent – 50/cs;Salter Labs; Arvin; CA 93203Intended usage: respiratory therapy. | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
Salter Laboratories; Division of Regulatory Affairs | Oct-26-2011 | Nebulizer – Nebulizer (adult elastic strap style aerosol mask 7′ tube – 50/cs); Latex FreeSalter Labs; Arvin; CA 93203Intended usage: respiratory therapy. | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
Salter Laboratories; Division of Regulatory Affairs | Oct-26-2011 | Mask adult; oxygen; medium concentration; elastic strap & non-breathing – Mask adult; oxygen; medium concentration; elastic strap style w. 7′ tube (Linde) 50/csMask; adult; oxygen; high concentration; non-rebreathing; elastic strap style w/ 7′ tube and safety vent – 50/cs;Mask adult; oxygen; high concentration; non-rebreathing; w/7′ tube w/out safety vent – 50/cs;Salter Labs; Arvin; CA 93203Intended usage: respiratory therapy. | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
GE Healthcare; LLC | Oct-26-2011 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM – GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL).The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer. | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
GE Healthcare; LLC | Oct-26-2011 | GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. – GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM.The Senographe DS system generates digital mammographic images; which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems. | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
CORPAK MedSystems | Oct-25-2011 | CORFLO 300 Enteral Pump – CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems; Wheeling; IL 60090; catalog/reorder #20-0500.Intended to deliver formula to patients requiring tube feedings. | Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage; the keypad may not function; and the possibility of motor mount failure. |
Invivo Corporation | Oct-25-2011 | MRI Patient Monitoring System – "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***".Note: REF 453564155341; REF 453564181201; and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner. | Philips Invivo Corporation of Orlando; FL is recalling their Expression MRI Patient Monitoring System. During transport of the system’s cart with a docked Display Controller Unit (DCU); a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall. |
Carl Zeiss Meditec; Inc. | Oct-24-2011 | OPMI VARIO 700 Surgical Microscope – OPMI VARIO 700 Surgical Microscope.Manufactured by: Carl Zeiss Meditec AG;Oberkochen; Germany.Provide a magnified view of the surgical field. | An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B083004742.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B053003318.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum; Side Cut Only. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: 319461; B093004589.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B073004223.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B123005596.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot numbers: B133005588.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
Smith & Nephew; Inc. Endoscopy Division | Oct-21-2011 | ENDOSCOPIC Camera – Smith & Nephew; HD1200 Autoclavable Camera HeadCatalog Number: 72203360Product Usage: Endoscope & Accessories | HD1200 camera heads may cause image issues |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: 319149.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF S-35DC***3.5 mm Coarse Diamond Ball; Extended Length. Use with SHORT Attachments.***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B133005432.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot numbers: 309600 and 315857.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF L-CRN***2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L Attachments.***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot numbers: 334040; 318914; and 316138.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B143004666.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – ‘***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot number: B113005418.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
The Anspach Effort; Inc. | Oct-21-2011 | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF TURQ-L5***5 mm Fluted Ball. Use with B-TURQ-L Attachment. ***ANSPACH***Sterile; Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort; Inc. 4500 Riverside Drive; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***"Lot numbers: 318219.Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc. initiated a recall on May 6; 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. |
Go Medical Industries Pty.; Ltd. | Oct-21-2011 | O’Neil Sterile Field Intermittent Urinary Catheter Kit – O’Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O’NEIL O’NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O’Neil 200 Churchill Ave; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford; HR4 9DQ; UK DISTRIBUTED IN THE USA BY: American Australian Medical; Inc. 1-888-880-8871***"Case of Catheter Kits labeled in part:"***The O’Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD200 Churchill Avenue; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO; NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***"This kit includes a Urinary Catheter and accessories including gloves; tissue; underpads; and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization. | O’Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release. |
Go Medical Industries Pty.; Ltd. | Oct-21-2011 | O’Neil Sterile Field Intermittent Urinary Catheter Kit – O’Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O’NEIL O’NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 16KPES SIZE:16Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O’Neil 200 Churchill Ave; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford; HR4 9DQ; UK DISTRIBUTED IN THE USA BY: American Australian Medical; Inc. 1-888-880-8871***"Case of Catheter Kits labeled in part:"***The O’Neil Sterile Field Urinary Catheter Kit REF: ONSM 16KPES Product No: AAM 8016KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD200 Churchill Avenue; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO; NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***"This kit includes a Urinary Catheter and accessories including gloves; tissue; underpads; and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization. | O’Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release. |
Go Medical Industries Pty.; Ltd. | Oct-21-2011 | O’Neil Sterile Field Intermittent Urinary Catheter Kit – O’Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O’NEIL O’NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 8KPES SIZE: 8Fr Product No: AAM 8008KPES***SINGLE USE ONLY***Original design by: Dr. George O’Neil 200 Churchill Ave; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford; HR4 9DQ; UK DISTRIBUTED IN THE USA BY: American Australian Medical; Inc. 1-888-880-8871***"Case of Catheter Kits labeled in part:"***The O’Neil Sterile Field Urinary Catheter Kit REF: ONSM 8KPES Product No: AAM 8008KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD200 Churchill Avenue; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO; NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***"This kit includes a Urinary Catheter and accessories including gloves; tissue; underpads; and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization. | O’Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release. |
Go Medical Industries Pty.; Ltd. | Oct-21-2011 | O’Neil Sterile Field Intermittent Urinary Catheter Kit – O’Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O’NEIL O’NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 10KPES SIZE: 10Fr Product No: AAM 8010KPES***SINGLE USE ONLY***Original design by: Dr. George O’Neil 200 Churchill Ave; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford; HR4 9DQ; UK DISTRIBUTED IN THE USA BY: American Australian Medical; Inc. 1-888-880-8871***"Case of Catheter Kits labeled in part:"***The O’Neil Sterile Field Urinary Catheter Kit REF: ONSM 10KPES Product No: AAM 8010KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD200 Churchill Avenue; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO; NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***"This kit includes a Urinary Catheter and accessories including gloves; tissue; underpads; and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization. | O’Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release. |
Go Medical Industries Pty.; Ltd. | Oct-21-2011 | O’Neil Sterile Field Intermittent Urinary Catheter Kit – O’Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O’NEIL O’NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 12KPES SIZE: 12Fr Product No: AAM 8012KPES***SINGLE USE ONLY***Original design by: Dr. George O’Neil 200 Churchill Ave; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford; HR4 9DQ; UK DISTRIBUTED IN THE USA BY: American Australian Medical; Inc. 1-888-880-8871***"Case of Catheter Kits labeled in part:"***The O’Neil Sterile Field Urinary Catheter Kit REF: ONSM 12KPES Product No: AAM 8012KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD200 Churchill Avenue; Subiaco; WA 6008; Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO; NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***"This kit includes a Urinary Catheter and accessories including gloves; tissue; underpads; and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization. | O’Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release. |
Synthes USA (HQ); Inc. | Oct-21-2011 | Synthes Spine Zero-P Instruments and Implants – Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device. | LABELING CORRECTION – Following review of labeling and promotional materials associated with the Zero-P Implant system; it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer. |
Data Innovations; Inc. | Oct-21-2011 | Instrument Manager software – Instrument Manager -Software Versions 8.05; 8.06; 8.07; 8.08; and 8.09.It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems; aiding the flow of laboratory information; including test orders and results; specimen information; and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals; PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. | The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result". |
Medtronic Perfusion Systems | Oct-20-2011 | Medtronic Disposable Pressure Display Set – Medtronic Disposable Pressure Display Set; Models 61000; 61006; 62000; 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic; Inc. 710 Medtronic Parkway; Minneapolis; MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter; cannula; or line pressures associated with cardiopulmonary bypass equipment and/or related products. | Pressure Display Set (models 61000; 61006; 62000; 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure. |
Stryker Howmedica Osteonics Corp. | Oct-20-2011 | Total Hip Joint Replacement – Total Hip Joint ReplacementAccolade TMZF Plus 127 Neck Angle V40 Hip Stem #3Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah; NJ 07430 A subsidiary of Stryker Corp.Stryker FranceZAC Satolos Green PusignanAv de Staolas Green 69881 MetziaeCedex FranceThe TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper. | Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem. |
Medtronic Perfusion Systems | Oct-20-2011 | Medtronic Pressure Display Box – Medtronic Pressure Display Box; Models 66000; 64000; 63000; 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The alarm will be activated when the pressure is equal to or beyond the set value. Manufacturer: Medtronic; Inc. 710 Medtronic Parkway; Minneapolis; MN 55431-5604.Product Usage: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery. | The DFU for the Medtronic Pressure Display Box; model 66000; states that; for display readings of -100 to +300 mmHg there will be an accuracy of +/-5 mmHg; and for display readings of +301 to +500 mmHg there will be an accuracy of +/-10 mmHg. Through reports from customers; Medtronic has become aware that the Pressure Display Box may not always accurately display readings. During use in the -40 |
Medtronic Perfusion Systems | Oct-20-2011 | Medtronic Disposable Pressure Display Set – Medtronic Intersept Custom Tubing Pack; which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic; Inc. 710 Medtronic Parkway; Minneapolis; MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter; cannula; or line pressures associated with cardiopulmonary bypass equipment and/or related products. | Pressure Display Set (models 61000; 61006; 62000; 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure. |
Biomet; Inc. | Oct-20-2011 | BIOMET MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE – MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE; STAINLESS STEEL; BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA.This device is used to mark the femoral neck resection level | Biomet has initiated this action following an investigation which identified that the blueprint calls forengraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. Theabove lots; as supplied to Biomet by a vendor; are engraved on only one side. To date; Biomet hasreceived 2 reports involving 2 units where the instrument was missing the engraving on one side. |
Siemens Healthcare Diagnostics; Inc. | Oct-19-2011 | Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges – Siemens Healthcare Diagnostics; Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges | Firm has confirmed customer complaints for low recovery of QC and patient samples. |
Lemaitre Vascular; Inc. | Oct-19-2011 | 9F Pruitt F3 Outlying Carotid Shunt with T-port – LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-portThe Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons; when inflated independently; act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock; through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow; to increase its visibility. Depth markings on the shunt body are for reference during insertion | Extended Expiration on the outer box label 2016-05; the correct expiration date is on the tray label: 2014-05 |
Cardiocommand Inc. | Oct-19-2011 | TAPSCOPE 550 – ***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series female connector thermistor. LOT xxxxxxx 400095-0250-C 100902. www.cardiocommand.com. ***REF #250-0010***TAPSCOPE 550F CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale; distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND; INC. Tampa; FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400156-B 091101.***REF #250-0025***TAPSCOPE 550F Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistor. FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale; distribution and use by or on the order of a licensed physician. Read Model 2A operator’s manual prior to initiating pacing procedures. Manufacturer: CARDIOCOMMAND; INC.Tampa; FL USA 33607. (800) 231-6370(813) 289-5555. www.cardiocommand.com. 400216-A 100902. | CardioCommand; Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity; which can result in the inability to reliably pace and/or record ECG. |
Cardiocommand Inc. | Oct-19-2011 | TAPSCOPE 550 – ***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale; distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND; INC. Tampa; FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101.***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale; distribution and use by or on the order of a licensed physician. Read Model 2A operator’s manual prior to initiating pacing procedures. Manufacturer: Tampa; FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902. | CardioCommand; Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity; which can result in the inability to reliably pace and/or record ECG. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 3.5mm; 0 SUTURE; REF 5100-0012; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 3.5mm; 2 SUTURE; REF 5100-0014; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 5.0mm; 0 SUTURE; REF 5100-0016; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 5.0mm; 2 SUTURE; REF 5100-0018; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 7.5mm; 2 SUTURE; REF 5100-0020; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 1.9mm; 2.0 SUTURE; REF 5100-002; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 1.9mm; 0 SUTURE; REF 5100-004;1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 2.5mm; 2.0 SUTURE; REF 5100-006; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 2.5mm; 2 SUTURE; REF 5100-0010; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Wright Medical Technology Inc | Oct-18-2011 | ANCHORLOK – ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM; 2.5mm; 0 SUTURE; REF 5100-008; 1 each; STERILE R; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002Product Usage: The instrument is used as a soft tissue anchor | The product is labeled with an expiration date without adequate justification. |
Sonosite; Inc. | Oct-18-2011 | MicroMaxx ultrasound system and M-Turbo ultrasound system – MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound.General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. | This is a software anomaly. In some circumstances; if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display; the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment. |
Impac Medical Systems Inc | Oct-17-2011 | SEQUENCER – Impac Medical Systems SequencerProduct Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment; to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine; via the machines communication interface; and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings; treatment is prohibited. At appropriate points during the treatment; the actual delivered values are recorded to provide treatment tracking. | Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq. |
Terumo Cardiovascular Systems Corporation | Oct-17-2011 | Sarns Rigid Intracardiac Sucker – Sarns Rigid Intracardiac Sucker. The subject device is a single use; sterile device with a 7.0 mm (21 FR) tip and 1/4 connector | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker. |
Terumo Cardiovascular Systems Corporation | Oct-17-2011 | Sarns Adult Rigid Intracardiac Sucker; bulk; non-sterile – SARNS INTRACARDIAC SUCKER; BULK; NON-STERILE | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker. |
Beckman Coulter Inc. | Oct-17-2011 | Access¿ Immunoassay Systems TOTAL ¿hCG – Access Immunoassay Systems Total ¿hCG.The Access Total ¿hCG assay is a paramagnetic particle; chemiluminescent immunoassay for the quantitative determination of total ¿hCG levels in human serum and plasma using the Access Immunoassay Systems. | The recall was initiated because Beckman Coulter has confirmed that certain Access Total ?hCG reagent packs show decreased stability from the date of manufacture; which may lead to increased imprecision. |
Abbott Molecular | Oct-14-2011 | Abbott m2000rt System software – Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc.; Des Plaines; IL 60018 USA; catalog #09K15-01The Abbott m2000rt System provides for real-time measurement of the stages of the polymerase chain reaction (PCR). Real-time PCR measures PCR amplification as it occurs; cycle-by-cycle; allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR. | The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column header. This causes a mismatch between specific concentration values and the designated calibrators and controls in the final results; which could cause an inval |
ArthroCare Corporation | Oct-14-2011 | MiniMagnum Knotless Fixation Device – ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007;Product is manufactured and distributed by ArthroCare Corporation; Sunnyvale; CAThe MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair; SLAP lesion repair; acromio-clavicular separation; rotator cuff repair; capsule shift/capsule-Iabral reconstruction; biceps tenodesis and deltoid repair. Ankle: Lateral instability; medial instability; Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair; biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament; posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction; ITB tenodesis; patellar ligament and tendon avulsions. | ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant. |
Angiodynamics; INC | Oct-13-2011 | 8F Smart Port CT. – 8F Smart Port CT; Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics; INC.The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and 8Fr. Introducer Kit. | The product may contain an incorrect size catheter and introducer. |
Angiodynamics; INC | Oct-13-2011 | Safe Sheath ULTRALITE 8F Safe Sheath Introducer. – 8F Safe Sheath Introducer; Catalog number: V18; AngioDynamics; INC.The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure. | The product may contain an incorrect size catheter and introducer. |
Interventional Spine Inc | Oct-13-2011 | PERPOS PLS System Single Use – PERPOS PLS System; Single Use; CATALOG #’s 9045-01 & 9045-02. Interventional Spine; Inc.A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw; resulting in difficulty screwing the facet screw into the bone.Use of this product may result in a delay of the surgical procedure |
Interventional Spine Inc | Oct-13-2011 | Reusable BONE-LOK PLS System; – Reusable BONE-LOK PLS System; Catalog #’s: 9039-01 and 9039-02.Interventional Spine; Inc.A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe. | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw; resulting in difficulty screwing the facet screw into the bone.Use of this product may result in a delay of the surgical procedure |
Interventional Spine Inc | Oct-13-2011 | PERPOS Driver – PERPOS Driver; Catalog # 6112Interventional Spine; Inc.A cannulated; driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01; 9045-02); a component of the Reusable BONE-LOK PLS System (9039-01; 9039-02); or as a stand-alone tool. | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw; resulting in difficulty screwing the facet screw into the bone.Use of this product may result in a delay of the surgical procedure |
Edan Instruments; Inc. | Oct-12-2011 | ECG Cable – ECG Cable Part Number: 01.57.471017 for use with the SE-1 series; SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series; SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However; the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag; as an accessory putting together with ECG machine in the package box. | The 3 leads of the cable; RL; LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue. |
Worldwide Medical Technologies; LLC | Oct-12-2011 | Prostate Seeding Needle; Applicator Technique – Prostrate Seeding Applicator Needle. Product code PSS1820ATPacked in boxes of (25) with five Single Packs and four five packs or as singles or five packs.Worldwide Medical Technologies; LLCUsed to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate | Length of the cannula hub is longer and may not permit a fit with the Applicator |
Richard-Allan Scientific Company | Oct-12-2011 | Thermo Scientific Microm – Thermo Scientific Microm: Rotary Microtome: REF HM355S-3Used for slicing tissue blocks. | The firm has received two complaints of finger lacerations in operators of this device. |
Siemens Healthcare Diagnostics; Inc. | Oct-12-2011 | Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) – Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module. | Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator; lot 1AD045 an upward shift in patient and QC results may be observed. |
Exalenz Bioscience Ltd | Oct-12-2011 | IDkit:HP" Two Test System – IDkit:HP" Breath Test for Detection of H. pylori; Manufactured by: Exalenz Bioscience Ltd 4 Ha’ maayan St. Modiin; Israel 71700; Distributed by: Exalenz Bioscience Inc.; 1313 N. Market St.; Sute 5100; Wilmington; DE 19808 USAProduct Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable; non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing. | The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted). |
Boston Scientific CRM Corp | Oct-12-2011 | LATITUDE¿ Paceart Integration Software – LATITUDE¿ Paceart Integration Software; version 1.00 Model 6472.LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However; the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493.When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic’s Paceart system. | Boston Scientific has determined that under certain conditions; LATITUDE Paceart Integration (LPI) softwaremay not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report. |
Accuray Incorporated | Oct-11-2011 | CyberKnife Robotic Radiosurgery System – CyberKnife Robotic Radiosurgery System; Synchrony Respiratory Tracking System (Robocouch Patient Positioning System); a Radiation Therapy Device. Model Numbers: 026430; 028186. Product is manufactured and distributed by Accuray; Inc.; Sunnyvale; CA | A report and investigation determined that the set screws; which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly. |
X Spine Systems Inc | Oct-11-2011 | Axle Interspinous Fusion System Torque Driver Handle – Axle Interspinous Fusion System Torque Driver Handle; Model #: X060-0323; Lot # 525941; S/Ns 001-017; Lot # 525942; S/Ns 001-050; Mfr. By: Bradshaw Medical Inc.; Kenosha; WI 53144The Axle Torque Driver Handle is used to lock the set screw into the locking plate. | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed. |
Accuray Incorporated | Oct-11-2011 | CyberKnife Robotic Radiosurgery System – CyberKnife Robotic Radiosurgery System; Synchrony Respiratory Tracking System (Standard Treatment Couch).Synchrony Respiratory Tracking System; a Radiation Therapy Device; Model Numbers: 026429; 028185.Product is manufactured and distributed by Accuray; Inc.; Sunnyvale; CA | A report and investigation determined that the set screws; which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly. |
Beckman Coulter Inc. | Oct-07-2011 | Coulter PrepPlus 2 – Coulter PrepPlus 2; Part Number: 378600; Serial Numbers: 1001008698; 1001008699; and 10018700.Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system; designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. | The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in the vertical mounts; the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. This misalignment yields impaired reagen |
Olympus America Inc. | Oct-07-2011 | OLYMPUS ViziShot EBUS Aspiration Needle – OLYMPUS ViziShot EBUS Aspiration NeedleEndobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) – the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. | Firm has received complaints from users of the ability to wipe material from the needle’s stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n |
Philips Healthcare Inc. | Oct-07-2011 | Philips Medical – MDC PACS – release R2.3 SP1 .Phillips HealthcareAndover; MassachusettsA software application that is used for receiving; managing; archiving; distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). | Clinical measurements on true size printouts may be inaccurate |
Tcoag Us; Incorporated | Oct-07-2011 | Minutex D-Dimer – Minutex D-Dimer ; Trinity Biotech plc;Bray;Co. Wicklow;Ireland.Tel: (353) 1 276 9800;Fax: (353) 1 276 9888;Web: www.trinitybiotech.comMinutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer. | There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer. |
Siemens Healthcare Diagnostics; Inc. | Oct-07-2011 | Dimension Vista(R) Cuvettes – Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an 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 fluid. Vista (TM) system chemical and immunochemical applications utilize photometric; turbidimetric; chemiluminescence; nephelometric and integrated ion selective multisensor technology for clinical use. | Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is related to a molding defect with the Cuvette flange or "wing" breaking; resulting in an error condition. Therefore; patient results are not impacted. |
Deroyal Industries; Inc. Lafollette | Oct-06-2011 | DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits – Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia Circuit; REF 86-001737; Rx Only; NON-STERILE; Manufactured by: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA; Lot Number 25660996(2) DeRoyal (R) Adult Anesthesia Circuit; REF 86-001781; Rx Only; NON-STERILE; Manufactured by: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA; Lot Numbers: 25574115; 25624514; 25661260; 25702578; 25766272; 25835901; 25835910; 25873406; 25906061; 25960681(3) DeRoyal (R) Latex Safe Anesthesia Kit; REF 86-001641; Rx Only; NON-STERILE; Manufacturer: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA: Lot Numbers: 25573171; 25765667; 25834853; 25834861(4) DeRoyal (R) Custom Anesthesia Kit; REF 86-001619; Rx Only; NON-STERILE; Manufacturer: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA: Lot Number 25573155(5) DeRoyal (R) Anesthesia Kit; REF 86-001669; Rx Only; NON-STERILE; Manufacturer: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA: Lot Numbers: 25313484; 25702324; 25977977Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector; adaptor; and Y-piece. | The firm manufactured kits containing a HCH device; manufactured by Vital Signs; that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient. |
Deroyal Industries; Inc. Lafollette | Oct-06-2011 | DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits – DeRoyal (R) Heat/Moist Exchange; REF 83-000042; Rx Only; NON-STERILE; Manufacturer: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector; adaptor; and Y-piece. | The firm manufactured kits containing a HCH device; manufactured by Vital Signs; that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient. |
Biomet Microfixation; Inc. | Oct-05-2011 | Latex Free Rubber Band – Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND; LATEX FREE SMALL; HEAVY; 300/PACKAGE 4MM; (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive; Jacksonville; FL 32218 USA www.biometmicrofixation.com***."Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL; INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***"Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire. | On 09/18/2011; Biomet Microfixation; Jacksonville; FL; recalled their SP-2411; Rubber Band; Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm’s HHE identified this as a potential high health risk to the patients or end users with latex allergies. |
Hospira Inc. | Oct-04-2011 | Plum A+ Single Channel Infusion Pumps – Plum A+ Single Channel Infusion Pumps; Hospira; Inc.; Lake Forest; IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 – software version 10.3 c) list 12391 – software version 11.3 d) list 20679 – Hospira MedNet Software e) list 20792 – Driver Product Usage: The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide; as well as alternate site and home healthcare; standardization. With their primary line; secondary line; and piggyback fluid delivery capability; the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield¿ needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system. | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. |
Hospira Inc. | Oct-04-2011 | Plum A+ Hyperbaric Single Channel Infusion Pumps – Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira; Inc.; Lake Forest; IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. |
Hospira Inc. | Oct-04-2011 | Plum A+3 Triple Channel Infusion Pumps – Plum A+3 Triple Channel Infusion Pumps; Hospira; Inc.; Lake Forest; IL 60045; the pumps were sold under the following configurations: a) list 12348 – software version 10.3; b) list 12618 – software version 11.3; c) list 20678 – Hospira MedNet software Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide; as well as alternate site and home healthcare; standardization. With their primary line; secondary line; and piggyback fluid delivery capability; the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield¿ needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system. | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. |
Smiths Medical ASD; Inc. | Oct-04-2011 | CADD¿-Solis ambulatory infusion pumps. – Smiths Medical; CADD¿-Solis ambulatory infusion pumps; Models 2100; REF 21-2101-0200-51 and 2110; REF 21-2111-0100-51; Rx Only.Smiths Medical ASD; Inc.; St Paul; MN 55112CADD¿-Solis ambulatory infusion pumps; Models 2100 and 2110; are indicated for intravenous; intra-arterial; subcutaneous; intraperitoneal; in close proximity to nerves; into an intraoperative site (soft tissue; body cavity/ surgical wound site); epidural space; or subarachnoid space infusion. These pumps are intended for therapies that require a continuous rate of infusion; patient-controlled demand doses; or both (such as patient-controlled analgesia). | Smiths Medical has become aware of an adverse trend in reports of non-delivery/ significant under-delivery of fluids when the CADD? Medication Cassette Reservoir is not correctly latched to the pump.EXPANDED: On 7/14/11; Smith Medical expanded this recall to include all consignees with affected pumps. |
Osteomed; Lp | Oct-04-2011 | OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft – OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road; Addison; Texas 75001 | Two of the Implant Driver Assembly tips were reported to break during surgery. |
Cyberonics; Inc | Oct-04-2011 | Cyberonics – Model 104 VNS Therapy Demipulse Duo Generator Cyberonics; Inc. Houston; Texas; Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page.Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures; which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. | An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient’s Model 103 Generator. |
Cyberonics; Inc | Oct-04-2011 | Cyberonics – VNS Therapy Demipulse Model 103 Generator Cyberonics; Inc. Houston; Texas; Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page.Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures; which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. | An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient’s Model 103 Generator. |
Cochlear Americas Inc. | Oct-03-2011 | Cochlear Nucleus CI512 Cochlear Implant – Cochlear Nucleus CI512 Cochlear Implant; REF Z209051; New with Nucleus 5; Sterile EO; Made in Australia; Cochlear Ltd 14 Mars Road; Lane Cove 2066; Australia.The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve. | Cochlear implant may shut down and cease to function. |
Medtronic Navigation; Inc | Oct-03-2011 | Right Long Tactile Probe – Probe; Tactile; Right; ASM; Long; Part #962011S;Medtronic Navigation; Louisville; CO 80027.Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. | Distal end of tactile probe may break off during use. |
Medtronic Navigation; Inc | Oct-03-2011 | Left Long Tactile Probe – Probe; Tactile; Left; ASM; Long; Part #962009S; Medtronic Navigation;Louisville; CO 80027.Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. | Distal end of tactile probe may break off during use. |
B Braun Medical; Inc | Oct-03-2011 | Outlook ES Safety Infusion System – Outlook ES Safety Infusion System; Model 621-100ES; 621-200ES; 621-300ES; and 621-400ESB. Braun Medical Inc.; 1601 Wallace Drive; Suite 150; Carrollton; TX 75006The Outlook ES pump is intended for use with B. Braun Medical Inc.; Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. | The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel. |