Class I recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Lee Medical International Inc | Sep-07-2011 | Custom dialysis prep kits – Custom dialysis prep kits labeled as follows: KIDNEYCARE; 125/CS; LOT #A1160; EXP 7-12; BIN 35A; Lee Medical International; Inc.; New Orleans; LA 70123MESCALERO-HEMO; 200/CS; LOT #B1113; EXP 8-12; Lee Medical International; Inc.; New Orleans; LA 70123DAV-MT-POCONO-H; 200/CS; LOT #B1123; EXP 8-12; BIN 45B; Lee Medical International; Inc.; New Orleans; LA 70123ADV-CATH-ISL44; 100/CS; LOT #B1127 EXP 8-12; BIN 34B; Lee Medical International; Inc.; New Orleans; LA 70123ADV-HEMO-15G; 100/CS; LOT #B1128; EXP 8-12; BIN 34A; Lee Medical International; Inc.; New Orleans; LA 70123NORTHHUDSON-C; 100/CS; LOT #B1134; EXP 8-12; BIN 42B; Lee Medical International; Inc.; New Orleans; LA 70123NORTHHUDSON-H; 75/CS; LOT #B1135; EXP 8012; BIN 42B; Lee Medical International; Inc.; New Orleans; LA 70123JOHNHAYES-HEMO; SMALL GLOVES; LOT #B1143; B1144; and B1145. EXP 8-12; 100/CS; Lee Medical International; Inc.; New Orleans; LA 70123JOHNHAYES-HEMO; MEDIUM GLOVES; LOT #B1146 and B1147; EXP 8-12; Lee Medical International; Inc.; New Orleans; LA 70123JOHNHAYES-SUB; SMALL GLOVES; 100/CS; LOT #B1148; EXP 8-12; Lee Medical International; Inc.; New Orleans; LA 70123JOHNHAYES-SUB; SMALL GLOVES; LOT #B1149; EXP 8-12; Lee Medical International; Inc.; New Orleans; LA 70123SNCH-CATH; 50/CS; LOT #B1152; EXP 8-12; BIN 43A; Lee Medical International; Inc.; New Orleans; LA 70123COMMUNITY-HEMO; 125/CS; LOT #B1156; EXP 8-12; Lee Medical International; Inc.; New Orleans; LA 70123FLAMS-HEMO; 125/CS. LOT #B1162; EXP 8-12; BIN 38B; Lee Medical International; Inc.; New Orleans; LA 70123KINDEYSPA-HEMO; 125/CS; LOT #B1161; EXP 8-12; BIN 35B; Lee Medical International; Inc.; New Orleans; LA 70123DAV-POCONO-H; 500/CS; LOT #C1107; EXP 9-12; Lee Medical International; Inc.; New Orleans; LA 70123DAV-POCONO-CATH; 75/CS; LOT #C1108; EXP 9-12; BIN 43B; Lee Medical International; Inc.; New Orleans; LA 70123DAV-MT-POCONO-H; 200/CS; LOT #C1109; EXP 9-12; BIN 45B; Lee Medical International; Inc.; New Orleans; LA 70123MESCALERO-HEMO; 200/CS; LOT #C1110; EXP 9-12; Lee Medical International; Inc.; New Orleans; LA 70123KIDNEYTRMT-HEMO; 125/CS; LOT #C1112 and C1123; EXP 9-12; BIN 45A; Lee Medical International; Inc.; New Orleans; LA 70123DAV-POCONO-H; 500/CS; LOT #C1126; EXP 9-12; Lee Medical International; Inc.; New Orleans; LA 70123METHODIST-HEMO; 150/CS; LOT #C1139; EXP 9-12; Lee Medical International; Inc.; New Orleans; LA 70123KINGMAN-HEMO; 150/CS; LOT #C1141; EXP 9-12; Lee Medical International; Inc.; New Orleans; LA 70123DAV-PALMERTON-H; 200/CS; LOT #C1145; EXP 9-12; BIN 43B; Lee Medical International; Inc.; New Orleans; LA 70123EMANUEL-CATH; 100/CS; LOT #C1146; EXP 9-12; BIN 34B; Lee Medical International; Inc.; New Orleans; LA 70123Product Usage: custom dialysis prep kits | Firm manufactured custom dialysis kits with Povidone Iodine (PVP) Prep Pads which were recalled by H & P industries. Those pads were subsequently recalled due to possible bacterial contamination. |
Lee Medical International Inc | Sep-23-2011 | Custom Dialysis prep kits – Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44; 100/CS; LOT #K1018; EXP 5-12; BIN 34B; COMMUNITY-CATH; 150/CS; LOT #K1052; EXP 5-12; BIN 36B; COLUMBUS-CATH; 50/CS; LOT #1080; EXP 05-12; BIN 39B; RENALSG-CATH; 75/CS; LOT #L1046; EXP 6-12; BIN 40B; SUNYDOWN-HEMO; 100/CS; LOT #l1015; EXP 6-12; BIN 28A; KIDNEYCARE 125/CS; LOT #l1070; EXP 6-12; METHODIST-CATH; 75/CS; LOT #L1072; EXP 6-12; METHODIST-HEMO; 150/CS; LOT #L1073; EXP 6-12; MERCYMED-CATH; 75/CS; LOT #L1077; EXP 6-12; BIN 39A and SANTACLA-CATH; 75/CS; LOT #A1118; EXP 7-12; BIN 44A.Product Usage: custom dialysis prep kits | The firm used alcohol triple swabstick and prep pads manufactured by H & P Industries in the manufacture of their custom dialysis kits. Those swabsticks and pads were subsequently recalled due to possible bacterial contamination. |
Class II recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Cincinnati Sub-Zero Products Inc | Sep-01-2011 | WarmAir Model 135 Hyperthermia System and Blankets – Operations and Technical Manuals for the firm’s WarmAir Model 135 Hyperthermia System (115V; 100V; and 230/240V); 510 (k) #K101148; Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to … a blanket that is placed over or around adult; pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities; surgical facilities; hospitals including the Post-anesthesia Care Unit (PACU); Intensive Care Unit (ICU); Surgical Intensive Care Unit (SICU); Emergency Room (ER); Operating Room (OR); medical and surgical floors; or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before; during; and after surgical procedures. Used to raise a patient’s temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket. | Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations. |
GE Healthcare; LLC | Sep-01-2011 | SIGNA 3.0T MR750 SYSTEM – GE Healthcare; 3.0T Signa MR750 (Marketing Name: GE Discovery MR750)Product Usage: The GE Sigma MR750 System is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique anatomical images; spectroscopic images; parametric maps; and/or dynamic images of the 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 GE Sigma MR750 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra; when interpreted by a trained physician yield information that may assist in diagnosis. | GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w; Discovery MR450; Discovery MR750; Brivo MR355; Optima MR360) that may impact patient safety.1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with |
Steris Corporation | Sep-01-2011 | SYSTEM 1E Liquid Chemical Sterilant Processing System – SYSTEM 1E Liquid Chemical Sterilant Processing System; Model # P6500; S/N: 400001 through 405005; Mfr. By: STERIS Corporation; Mentor; OH 44060.Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices; including endoscopes and their accessories. | STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system. |
GE Healthcare; LLC | Sep-01-2011 | Optima MR450w – GE Healthcare; 1.5T Optima MR450wProduct Usage: The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique anatomical images; spectroscopic data; parametric maps; or dynamic images of the structures or functions of the entire body. The indication for use includes; but is not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. Depending on the region of interest being imaged; contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra; when interpreted by a trained physician yield information that may assist in diagnosis. | GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w; Discovery MR450; Discovery MR750; Brivo MR355; Optima MR360) that may impact patient safety.1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with |
GE Healthcare; LLC | Sep-01-2011 | DISCOVERY MR450 – GE Healthcare; Discovery MR450Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique anatomical images; spectroscopic images; parametric maps; and/or spectra; dynamic images of the structures and/ or functions 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. Depending on the region of interest being imaged; contrast agents may be used. The images produced by the Discovery MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra; when interpreted by a trained physician yield information that may assist in diagnosis. | GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w; Discovery MR450; Discovery MR750; Brivo MR355; Optima MR360) that may impact patient safety.1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with |
Beckman Coulter Inc. | Sep-01-2011 | Unicel DxH 800 Coulter Cellular Analysis System – Unicel DxH 800 Coulter Cellular Analysis SystemProduct Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD The UniCel DxH 800 Analyzer is a quantitative; automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: 1. Complete Blood Count (CBC); Leukocyte 5 Part Differential (Diff); Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. 2. Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal; serous and synovial) (BF). | The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube presentation station. When the tension on the tubing is severe; the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. The misal |
Steris Corporation | Sep-01-2011 | Reliance Vision Single Chamber Washer/Disinfector – Reliance Vision Single Chamber Washer/Disinfector; Model # 1802983;The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils; trays; glassware; bedpans and urinals; rubber and plastic goods; simple hard-surfaced rigid surgical instruments such as forceps and clamps; theatre shoes and other similar and related articles found in healthcare facilities. | STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit. |
bioMerieux; Inc. | Sep-02-2011 | VIDAS Chlamydia kits – VIDAS Chlamydia test kitsVIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments; for the detection of Chlamydia antigen in endocervical or urethral specimens; using the ELFA technique (Enzyme Linked Fluorescent Assay. | Complaints were received of high rates of false positive results; leading to unnecessary antibiotic therapy being prescribed to patients. |
Orthofix; Inc. | Sep-07-2011 | Ratcheting Torque Limiting Handle – Ratcheting Torque Limiting Handle; Catalog Number 52-1012; Orthofix Spinal Implants; Firebird Spinal Fixation System; Firebird Spinal Fixation System DDD Instrument Case.Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct. | Upon reaching torque limit; there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse. |
TiSport; Llc | Sep-07-2011 | TiLite ZR Series 2 and ZRA Series 2 Wheelchairs – TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite.The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals. | The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off. |
Picis Inc. | Sep-07-2011 | Picis ED PulseCheck-Software – Picis ED PulseCheck-Software; transmission & storage; patient dataService Pack v5.0 L and MThis product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources; such as health care professionals; medical devices connected to the system; and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals. | Software does not display appropriate allergy interaction warning |
Medela Inc | Sep-08-2011 | Invia Wound Therapy Tier I Wound Dressing Kit; 10 MM Flat Drain – Wound Dressing Kit – Tier I; 10 MM Flat Drain; product code 0877061.Medela Healthcare; McHenry; IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain; antimicrobial gauze pad; non-adherent wound contact layer; transparent dressing; tubing clamp; barrier film wipe; adhesive tape; sterile saline; and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit; 15 Fr Round Channel Drain; product 0877067; lot 370118 | Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set; Tier I; 10 MM Flat Drain"; were labeled incorrectly as "0877067 Wound Dressing Set; Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set; Tier 1;10 MM Flat Drain". |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET4535 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET4535A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET4548 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET6048AThe ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET6035The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET6035AThe ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET6048The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Covidien LP | Sep-08-2011 | DUET TRS Loading Units – DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET4548AThe ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection; and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Sterility of the device is compromised due to a breach in the sterile packaging |
Coloplast Manufacturing US; LLC | Sep-09-2011 | SenSura and Assura Post-op Pouches – Coloplast Corp.-MN 06093; Country of origin: DK ( SenSura 19011 Post-Op; ostomy bag with window; 100 mm ; Sterilized using ethylene oxide; SenSura 19010 Post-Op ;ostomy bag with window; 70 mm ; Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows; 10-76 mm Sterilized using ethylene oxide; Manufacturer: Colopast A/S 3050 Denmark.)Coloplast Corp.-MN 06093; Country of origin: HU ; No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only; Sterile EO; 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op; pouches without window; single use; Sterile EO; 1/2" -2 3/4"/13-70mm ; Cut-to fit.; No. 128080 1400 ( Assura Post Op; 12808; pouches with window; single use; Sterile EO; 2 3/4 / 70 mm ; Cut- to- fit) ; Manufacturer: Colopast A/S 3050 Denmark.These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen; the soft drainable outlet accommodates the post-operative liquid output; and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter; non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital. | On July 19; 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these results it was determined that all affected lots be recalled and quarantined. This affects lots manufactured and distributed from January 2010 until July 19; 2011. |
Northgate Technologies; Inc. | Sep-09-2011 | Olympus Fluid Aspiration Set – Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc.; Two Corporate Center Drive; Melville; NY 11747-3157; catalog #72-00114-0The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures. | The Red Tag was assembled to the wrong end of the silicone tubing. The Red Tag indicates how the fluid aspiration tubing set is loaded into the Olympus SP-2 Fluid Irrigation and Aspiration Pump. |
C P Medical Inc. | Sep-09-2011 | Monomid Non-Absorbable Suture – Monomid Non-Absorbable Suture are blue; monofilament synthetic absorbable suture; with different sizes and different needle sizes.The products are labeled in parts.These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular; ophthalmic; and neurological surgery. | Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material. |
Boston Scientific CRM Corp | Sep-09-2011 | LATITUDE¿ Patient Management System Communicator – LATITUDE¿ Patient Management System Communicator; Model 6482.The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. | Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload; which is the information uploaded to the LATITUDE system from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted to the website. If the payload is not displayed; the pertinent data will not be available on the |
Terumo Cardiovascular Systems Corporation | Sep-09-2011 | Terumo Sarns Level Detect II Mount Pads – Terumo Sarns Level Sensor II Pads.Terumo Cardiovascular Systems Corporation.Used to attach level sensors to the sides of the venous reservoir. | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. |
Medtronic Spine LLC (formerly Kyphon Inc.) | Sep-09-2011 | KyphoPak Express Tray First Fracture; 15/2 with KyphX Osteo Introducer System – Kyphon brand KyphoPak Express Tray First Fracture; 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc); Sunnyvale; CADesigned to reduce kyphosis that results from vertebral body collapse due to osteoporosis. | Device was shipped past the labeled expiration date. |
Biosense Webster; Inc. | Sep-12-2011 | EP-Shuttle/Stockert J50/Stockert J70 – STOCKERT 70 Radio Frequency Generator; Catalog Number 57001 Indicated for use with a Biosense Webster; Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures.Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70 | Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator; to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product. |
Orthovita; Inc. | Sep-12-2011 | Orthovita(R) Cortoss(TM) Delivery Gun – Orthovita(R) Cortoss(TM) Delivery GunProduct Usage: Used for the application of Cortoss(TM) Bone Augmentation Material | Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material; which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report |
Ethicon Endo-Surgery Inc | Sep-12-2011 | ENDOPATH¿ ETS Compact Flex (240 mm shaft length) Linear Cutters – ENDOPATH¿ ETS Compact Flex (240 mm shaft length) Linear Cutters; Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery; LLC; Guaynabo; PR 00969The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection; resection; and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general; gynecologic; urologic; thoracic; and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH? ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device. |
Medtronic Inc. Cardiac Rhythm Disease Management | Sep-12-2011 | Medtronic FlexCath 3FC12 – Medtronic FlexCath; model 3FC12; Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction; withdrawal; and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion; injection through the center lumen; flushing; aspiration; blood sampling and pressure monitoring. Rx only. Sterilized using ethylene oxide. Manufacturer: Medtronic CryoCath LP; Kirkland; Quebec H9H 5H3; Canada.Product Usage: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning. | Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath; Model 3FC12. There wave been reports of blood and saline solution leaking out of; and air ingress into the hemostatic valve. This includes reported instances of the introduction of air bubbles through the valve during aspiration of the side port |
Spacelabs Healthcare; Incorporated | Sep-12-2011 | Spacelabs Medical Vital Signs Monitor; Model 91220 – The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display.The Spacelabs Medical; mCare 300; Model 91220; Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult; pediatric and neonate patient populations wherever there is a need for the monitoring of ECG; respiration; invasive or noninvasive blood pressures; body temperature; functional arterial oxygen saturation; or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. | There have been reports that the Spacelabs Medical Vital Signs Monitor; Model 91220; will not power up with AC power and will no longer charge the batteries. |
Hamamatsu Corporation | Sep-13-2011 | Micro Focus X-Ray generator – Hamamatsu model L10951-35 Micro Focus x-ray generator.The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies. | It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator. |
Straumann Manufacturing Inc. | Sep-13-2011 | Straumann coDiagnostiX – Straumann coDiagnostiX; version 8.0; used to guide a clinician in the proper implant selection; oral placement and the proper selection of an oral drill.Imaging processing System | Software version 8.0 has a software anomaly; in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed. |
Toshiba American Medical Systems Inc | Sep-13-2011 | TSX-101A: AQUILION 16; System; X-Ray; Tomography; Computed – TSX-101A: AQUILION 16; System; X-Ray; Tomography; ComputedX-Ray Tomography | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System; X-Ray; Tomography; Computed;TSX-301A: AQUILION One; System; X-Ray; Tomography; Computed;TSX-20IA: AQUlLlON LB; System; X-Ray; Tomography; Computed; and TSX-1O1A: AQUILION 16; System; X-Ray; Tomography; Computed due to several software issues that cause the scanners to function incorr |
Toshiba American Medical Systems Inc | Sep-13-2011 | TSX-201A: AQUlLlON LB; System; X-Ray; Tomography; Computed – TSX-201A: AQUlLlON LB; System; X-Ray; Tomography; ComputedX-Ray Tomography | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System; X-Ray; Tomography; Computed;TSX-301A: AQUILION One; System; X-Ray; Tomography; Computed;TSX-20IA: AQUlLlON LB; System; X-Ray; Tomography; Computed; and TSX-1O1A: AQUILION 16; System; X-Ray; Tomography; Computed due to several software issues that cause the scanners to function incorr |
Toshiba American Medical Systems Inc | Sep-13-2011 | TSX-301A: AQUILION One; System; X-Ray; Tomography; Computed – TSX-301A: AQUILION One; System; X-Ray; Tomography; ComputedX-Ray Tomography | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System; X-Ray; Tomography; Computed;TSX-301A: AQUILION One; System; X-Ray; Tomography; Computed;TSX-20IA: AQUlLlON LB; System; X-Ray; Tomography; Computed; and TSX-1O1A: AQUILION 16; System; X-Ray; Tomography; Computed due to several software issues that cause the scanners to function incorr |
Toshiba American Medical Systems Inc | Sep-13-2011 | TSX-301B: AQUILION Premium; System; X-Ray; Tomography; Computed – TSX-301B: AQUILION Premium; System; X-Ray; Tomography; ComputedX-Ray Tomography | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System; X-Ray; Tomography; Computed;TSX-301A: AQUILION One; System; X-Ray; Tomography; Computed;TSX-20IA: AQUlLlON LB; System; X-Ray; Tomography; Computed; and TSX-1O1A: AQUILION 16; System; X-Ray; Tomography; Computed due to several software issues that cause the scanners to function incorr |
The Anspach Effort; Inc. | Sep-13-2011 | Anspach Single Use; Sterile Bone Cutting Burrs model SIL-7-9 – Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted Ball.***Use with B-Silber***Attachment.***Use by 2015-01***ANSPACH***Manufacturer***Made in USA***The Anspach Effort; Inc.***4500 Riverside Drive***Palm Beach Gardens; FL 33410; USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court; Kingsmead Business Park***Frederick Place***High Wycombe; HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D053031534***.Cutting and Shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc.; Palm Beach Gardens; FL; is recalling their Anspach Single Use; Sterile Bone Cutting Burrs; catalog numbers; IMRI-S-8NS-M; M-6P; QD8-4OVD; S-5B-4; and SIL-7-9; lot #’s C323023789; C403026551; C473028567; C403026563; D153034013; D173034385; and C363024789; because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to |
The Anspach Effort; Inc. | Sep-13-2011 | Anspach Single Use; Sterile Bone Cutting Burrs model QD8-4OVD – Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 mm Diamond Oval. Use with***QD8 Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort; Inc.***4500 Riverside Drive***Palm Beach Gardens; FL 33410; USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court; Kingsmead Business Park***Frederick Place***High Wycombe; HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049563***.Cutting and Shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc.; Palm Beach Gardens; FL; is recalling their Anspach Single Use; Sterile Bone Cutting Burrs; catalog numbers; IMRI-S-8NS-M; M-6P; QD8-4OVD; S-5B-4; and SIL-7-9; lot #’s C323023789; C403026551; C473028567; C403026563; D153034013; D173034385; and C363024789; because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to |
The Anspach Effort; Inc. | Sep-13-2011 | Anspach Single Use; Sterile Bone Cutting Burrs model M-6P – Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***ANSPACH***Manufacturer***Made in USA***The Anspach Effort; Inc.***4500 Riverside Drive***Palm Beach Gardens; FL 33410; USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court; Kingsmead Business Park***Frederick Place***High Wycombe; HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D493042603***.Cutting and Shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc.; Palm Beach Gardens; FL; is recalling their Anspach Single Use; Sterile Bone Cutting Burrs; catalog numbers; IMRI-S-8NS-M; M-6P; QD8-4OVD; S-5B-4; and SIL-7-9; lot #’s C323023789; C403026551; C473028567; C403026563; D153034013; D173034385; and C363024789; because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to |
Philips Medical Systems (Cleveland) Inc | Sep-13-2011 | GEMINI TF64 Diagnostic Imaging System – Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems; Model Number: 882476; 510(k) #K081135; Serial Numbers: 9201; 9202; 9203; 9204; 9205; and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6; TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; brain; heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode; dynamic; and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. | The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur; it could impact the performance of reliability of the these PET/CT system units. |
Philips Medical Systems (Cleveland) Inc | Sep-13-2011 | GEMINI TF64 Diagnostic Imaging System – Philips GEMINI TF64 Diagnostic Imaging Systems; Model Number: 882471; 510(k) #K052640; Serial Numbers: 7502; 7504; 7506; 7514; 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6; TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; brain; heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode; dynamic; and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. | The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur; it could impact the performance of reliability of the these PET/CT system units. |
Philips Medical Systems (Cleveland) Inc | Sep-13-2011 | GEMINI TF16 Diagnostic Imaging System – Philips GEMINI TF16 Diagnostic Imaging Systems; Model Number: 882470; 510(k) #K052640; Serial Numbers: 7501; 7503; 7507; 7508; 7011; 7047; and 7174. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6; TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; brain; heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode; dynamic; and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. | The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur; it could impact the performance of reliability of the these PET/CT system units. |
The Anspach Effort; Inc. | Sep-13-2011 | Anspach Single Use; Sterile Bone Cutting Burrs model IMRI-S-8NS-M – Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick; Extends 8.9 mm;***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort; Inc.***4500 Riverside Drive***Palm Beach Gardens; FL 33410; USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court; Kingsmead Business Park***Frederick Place***High Wycombe; HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***.Cutting and Shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc.; Palm Beach Gardens; FL; is recalling their Anspach Single Use; Sterile Bone Cutting Burrs; catalog numbers; IMRI-S-8NS-M; M-6P; QD8-4OVD; S-5B-4; and SIL-7-9; lot #’s C323023789; C403026551; C473028567; C403026563; D153034013; D173034385; and C363024789; because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to |
The Anspach Effort; Inc. | Sep-13-2011 | Anspach Single Use; Sterile Bone Cutting Burrs model S-5B-4 – Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball; 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort; Inc.***4500 Riverside Drive***Palm Beach Gardens; FL 33410; USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court; Kingsmead Business Park***Frederick Place***High Wycombe; HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***.Cutting and Shaping bone including bones of the spine and cranium. | The Anspach Effort; Inc.; Palm Beach Gardens; FL; is recalling their Anspach Single Use; Sterile Bone Cutting Burrs; catalog numbers; IMRI-S-8NS-M; M-6P; QD8-4OVD; S-5B-4; and SIL-7-9; lot #’s C323023789; C403026551; C473028567; C403026563; D153034013; D173034385; and C363024789; because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to |
Varian Medical Systems; Inc. Oncology Systems | Sep-14-2011 | 4D Integrated Treatment Console – 4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5; all of 4DITC v 8.3;Varian Medical Systems; Palo Alto; CADesigned to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. | The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system. |
Varian Medical Systems; Inc. | Sep-14-2011 | Millennium and HD-120 MultiLeaf Collimators (MLC); Clinac – Varian Medical Systems Inc.; Millennium and HD-120 MultiLeaf Collimators (MLC); a component of the Clinac; All Varian Clinac using the collimator cover P/N 1106900-xx; Model Numbers: H14; H18; H27; H29; HCX; part of the Trilogy Radiotherapy Delivery System. | An improperly installed collimator cover may detach and fall from the machine; potentially striking the patient or nearby personnel. |
Pride Mobility Products Corp | Sep-14-2011 | Victory 10; 4 Wheel (SC710) – Victory 10; 4 Wheel (SC710)Mobility medical device | Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride’s Engineering drawings. |
Philips Healthcare Inc. | Sep-14-2011 | Philips Healthcare PCR Eleva Radiological Image Processing System – PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare; Inc.A computed radiography image processing system. | The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis |
The Anspach Effort; Inc. | Sep-14-2011 | Anspach Single Use; Sterile Bone Cutting Burs – Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with B-TURQUOISE Attachment.***ANSPACH***Manufacturer Made in USA***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: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***"Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Palm Beach Gardens; FL; is recalling their Single Use; Sterile Bone Cutting Burrs; Catalog #; S-1504TD; Lot #s D363039140. D323038110; D293037349 and Catalog # TURQ-434-4; Lot #s D343038845; D323038131; due to the burr being 2.0 mm longer than stated on the label. As a result; a hole drilled using this burr would be 2 mm deeper than the screw. |
The Anspach Effort; Inc. | Sep-14-2011 | Anspach Single Use; Sterile Bone Cutting Burs – Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***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: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***". Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort; Palm Beach Gardens; FL; is recalling their Single Use; Sterile Bone Cutting Burrs; Catalog #; S-1504TD; Lot #s D363039140. D323038110; D293037349 and Catalog # TURQ-434-4; Lot #s D343038845; D323038131; due to the burr being 2.0 mm longer than stated on the label. As a result; a hole drilled using this burr would be 2 mm deeper than the screw. |
Pride Mobility Products Corp | Sep-14-2011 | Victory 10; 3 Wheel (SC610) – Victory 10; 3 Wheel (SC610)Mobility medical device | Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride’s Engineering drawings. |
Philips Medical Systems (Cleveland) Inc | Sep-14-2011 | Brilliance iCT CT X-Ray System – Brilliance iCT Computed Tomography X-Ray System; 510 (k) #K060937; Model #728306; Serial Numbers: 100019; 100023; 100087; 100103; and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011.The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. Philips Medical’s Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors. |
Philips Medical Systems (Cleveland) Inc | Sep-14-2011 | Brilliance iCT SP X-Ray System – Brilliance iCT SP Computed Tomography X-Ray System; 510 (k) #K060937; Model #728311; Serial Numbers: 200005; 200013; and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011.The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. Philips Medical’s Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors. |
GE Healthcare; LLC | Sep-14-2011 | DATEX-OHMEDA TRUSAT PULSE OXIMETER – DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES; MODEL 3500 (GE Healthcare) | The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage; and overheating. The issue may impact patient or user safety. Potential for system or components to start on fire or explode (general case). |
Terumo Cardiovascular Systems Corporation | Sep-15-2011 | 8K Cardioplegia Monitor – Sarns 8000 Cardioplegia Monitor; Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K; Catalog Number 816373The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. | The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume. |
Synthes USA (HQ); Inc. | Sep-15-2011 | Synthes Matrix System – T1 Matrix Locking Cap – Synthes T1 Matrix Locking Cap of the Synthes Matrix System; Part Number 04.632.000.Intended for posterior pedicle screw fixation; posterior hook fixation; or anterolateral fixation. | Labeling Correction — The locking cap was not able to be loosened; resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw; cap; and rod). This poses a potential risk of significant prolongation of OR time. |
Angiodynamics Worldwide Headquarters | Sep-16-2011 | Soft-Vu Angiographic Catheter – ANGIODYNAMICS Angiographic Catheter; Soft-Vu Cobra (2) BRAIDED; 5 F x 90 cm x .035 in.; Catalog No./REF 10709105; STERILE; MANUFACTURED IN USA; AngioDynamics; Inc. 603 Queensbury Avenue; Queensbury; NY 12804Angiographic catheter | The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length. |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.0; REV 1; REV 1A; REV. 2XCoated 8:1 FX PACKItem Number: 73192Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 3; REV: 3A; REV:4FX; CP50 CENT. PKItem Number: 73386-01Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 4FX; CP50 CENT. PKItem Number: 73386Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 8 Comprensive X-COATED 8000 FX PKItem Number: 73252Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 1A; REV :1 X-COATED FX PKItem Number: 73191-01The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart.Terumo Cardiovascular Systems; Ashland; MA 01721 | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 2A; REV: 2BX-COATED FX PKItem Number: 73191Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 1 REV: 1ACOATED FX PKItem Number: 72985-02Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 0; REV: 1 REV: 4; REV: 6A; REV: 6B. REV: 6CCOATED FX PKItem Number: 72985-01Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | Terumo 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV OAPERFUSION W/4:1 CARDIOPLEGIAItem Number 72990Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; Rev O; REV 1; REV 1A; REV 2 X-COATED 8:1 FX PACKItem Number 73192Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; Rev OA FX 8:1 PACKItem Number :73315Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; Rev OX-Coated 8:1 CP No OXYItem Number: 73329Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.0 REV.0A; REV.1 X-Coated 4:1 CP50 FX PackItem Number: 73381Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV..1 X-Coated Stand Alone Adult PackItem Number: 73413Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.2; REV. 3PUMP & TABLE PACK 1/4Terumo Cardiovascular Systems; Ashland; MA 0172Item Number: 71038-05Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.3; REV. 5X-COATED 8:1 CARDIOPLEGIAItem Number: 71071-02Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.OBPERFUSION W/8:1 CARDIOPLEGIAItem Number: 71653-04Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.4; REV. 5X-COATED NEONATAL PACK 3/16"Item Number: 72651-02Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 0; REV: 2; REV:6X-Coated FX Perfusion PackItem Number: 73785Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV.0FX 8:1 PACKItem Number: 73329Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Adjustable Valve Item Number: 73631Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 2X-COATED 3/8 X 3/8 A-V LOOPItem Number: 73946Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 1X-COATED 3/8 X 1/2 A-V LOOPItem Number: 73954Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 5X-COATED FPS ADULT PACKItem Number: 73325Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 5STANDARD PACKItem Number: 71701Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV :10. REV 13; REV17; REV 18FX X-Coated Perfusion PackItem Number: 72941Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV :2. REV 2A; REV: 17; REV 18X-COATED FX PACKItem Number: 73191Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV :3. REV: 4; REV: 5; REV: 6; REV:7 X-Coated 8000 FX PACKItem Number: 73252 Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV : 2; REV: 4FX; CP50;CENT PackItem Number: 73386 Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV : 3General Low PrimeItem Number: 73563Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
Terumo Cardiovascular Systems Corp | Sep-16-2011 | TERUMO 3-T L. V. Control Valve – Cardiovascular Custom Procedure Kits; REV: 2; REV:2A; REV: 5; REV: 7 X-Coated FX PERFUSION PKItem Number: 72941-01Terumo Cardiovascular Systems; Ashland; MA 01721The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde now and air into the heart. | 3-T Medical Systems one way vent valves; included in the Custom Terumo Cardiovascular kits; may separate at the bond that holds the two halves |
St Jude Medical | Sep-16-2011 | Therapy Ablation Catheter – 7 F Therapy Ablation Catheter; 4 mm Tip Thermistor; Model (Reorder #) 83726; Description: 1304-7-25-XL-TH.St Jude Medical CompanyA sterile; single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. | The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter; 4 mm Tip Thermistor Quadripolar; were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling; St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose; correct version. |
St Jude Medical | Sep-16-2011 | Therapy Ablation Catheter – 7 F Therapy Ablation Catheter; 4 mm Tip Thermistor; Model (Reorder #) 83725; Description: 1304-7-25-L-TH.St Jude Medical CompanyA sterile; single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. | The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter; 4 mm Tip Thermistor Quadripolar; were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling; St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose; correct version. |
St Jude Medical | Sep-16-2011 | Therapy Ablation Catheter – 7 F Therapy Ablation Catheter; 4 mm Tip Thermistor; Model (Reorder #) 83724; Description: 1304-7-25-M-TH.St Jude Medical CompanyA sterile; single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. | The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter; 4 mm Tip Thermistor Quadripolar; were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling; St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose; correct version. |
Becton Dickinson & Co. | Sep-16-2011 | BD MAX GBS – BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use; For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. | Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient. |
Becton Dickinson & Co. | Sep-16-2011 | BD MAX RNA Extraction Kit RNA-3 – BD MAX RNA Extraction Kit RNA-3; Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplification and detection. The BD MAX RNA Extraction Kit has not been validated for use with any specific analytical test method. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. | Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack; associating sample results to wrong patient. |
Becton Dickinson & Co. | Sep-16-2011 | BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM); – BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM); Catalog Number 437503. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis; DNA extraction and removal of inhibitors. Following cell lysis; by a combination of heat and lytic enzymes; the released nucleic acid is captured by magnetic affinity beads. The beads; with the bound nucleic acids; are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits | Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack; associating sample results to wrong patient. |
Becton Dickinson & Co. | Sep-16-2011 | BD MAX DNA Extraction Kit DNA-2 (Whole Blood) – BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D barcode sample preparation reagent tubes *** For use with the BD MAX System ***to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis; DNA extraction and removal of inhibitors. Following cell lysis; by a combination of heat and lytic enzymes; the released nucleic acid is captured by magnetic affinity beads. The beads; with the bound nucleic acids; are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits | Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack; associating sample results to wrong patient. |
Becton Dickinson & Co. | Sep-16-2011 | BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) – BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses; which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis; DNA extraction and removal of inhibitors. Following cell lysis; by a combination of heat and lytic enzymes; the released nucleic acid is captured by magnetic affinity beads. The beads; with the bound nucleic acids; are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits | Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack; associating sample results to wrong patient. |
Deroyal Industries; Inc. Lafollette | Sep-16-2011 | Circumcision trays and packs – Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray; REF 50-5613; 1 Per Pack; Rx Only STERILE EO; Distributed by: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA; Made in Dominican RepublicLot Numbers: 20854003; 22892644(2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH; MEMORIAL HOSP TAL WEST; REF 89-5699; 1 Per Pack; Rx Only STERILE EO; Distributed by: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USA; Manufacturer: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USALot Number 20012949Circumcision Clamp | The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design. |
Deroyal Industries; Inc. Lafollette | Sep-16-2011 | Circumcision Clamp – DeRoyal (R) ST. Circumcision Clamp; REF 32-1622; 1 Per Pack; Rx Only STERILE EO; Distributed by: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; USACircumcision Clamp | The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design. |
Toshiba American Medical Systems Inc | Sep-16-2011 | TSX-101: Aquilion 32/64 – TSX-101: Aquilion 32/64; System; X-Ray; Tomography; Computed. | There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function; which adjusts the x-ray output in synchronization with the ECG waveform. |
Cardiac Science Corporation | Sep-19-2011 | Powerheart AED; G3; CardioVive AED; GE Responder AED; Nihon Kohden CardioLife AED – Powerheart Automated External Defibrillator (AED); G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation; if the victim is breathing; the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs; the device will charge automatically and be able to deliver therapy.Model numbers: Powerheart 9300A; 9300C; 9300D; 9300E; 9300P; 9390A; 9390E; CardioVive 92532; 92533; NK 9200G; 9231; and Responder 2019198; 2023440.Brand names: Powerheart AED; G3; CardioVive AED; GE ResponderAED; Nihon Kohden CardioLife AED. | Cardiac Science Corporation (CSC) has identified two errors; 0x48 and 0x99; that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state.CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro |
Angiodynamics Worldwide Headquarters | Sep-19-2011 | Profiler Balloon Catheter – ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER; Catalog No./REF 16801101; BALLOON DIAMETER 4MM; BALLOON LENGTH 2 CM; CATHETER LENGTH 40 CM; STERILE; MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue; Queensbury; NY 12804 Cardiovascular catheterization | The particular lots of Profiler PTA Balloon Catheters were labeled incorrectly. Lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and Lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm. |
Bayer Healthcare; LLC | Sep-19-2011 | Contour; Contour TS Blood Glucose Test Strips and Bonus Packs – Contour; Contour TS Blood Glucose Test Strips and Bonus PacksIntended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood | All 10- or 25- count glucose test strip vials; either loose vials or found in patient starter kits of Contour; Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which; under certain conditions; can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood |
Beckman Coulter Inc. | Sep-19-2011 | COULTER DxH Cell Lyse – COULTER DxH Cell Lyse; Part number 628018(1L) and 628019 (5L).The COULTER¿ DxH Cell Lyse is an erythrocyte lytic agent used for quantitativedetermination of hemoglobin; enumeration of NRBC; and counting and sizingleukocytes on UniCel¿ DxH 800 Coulter¿ Cellular Analysis System. | The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts;could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/?L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control. |
Angiodynamics Worldwide Headquarters | Sep-19-2011 | Profiler Balloon Catheter – ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER; Catalog No./REF 16801105; BALLOON DIAMETER 5MM; BALLOON LENGTH 4 CM; CATHETER LENGTH 40 CM; STERILE; MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue; Queensbury; NY 12804 Cardiovascular catheterization | The particular lots of Profiler PTA Balloon Catheters were labeled incorrectly. Lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and Lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm. |
Angiodynamics Worldwide Headquarters | Sep-19-2011 | UNI*FUSE INFUSION SYSTEM – ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE; Catalog No./REF 12401819; CATHETER SIZE 4F; CATHETER LENGTH 90 cm; INFUSION LENGTH 20 cm; OCCLUSION WIRE SIZE .035 in.; STERILE; AngioDynamics Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 | The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires. |
Angiodynamics Worldwide Headquarters | Sep-19-2011 | UNI*FUSE INFUSION SYSTEM – ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE; Catalog No./REF 12401818; CATHETER SIZE 4F; CATHETER LENGTH 90 cm; INFUSION LENGTH 10 cm; OCCLUSION WIRE SIZE .035 in.; STERILE; AngioDynamics Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 | The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires. |
Fresenius Medical Care Holdings; Inc. | Sep-20-2011 | Fresenius Medical CombiSet True Flow" – CombiSet¿ True Flow" 2008K@home BloodlinesFresenius Medical Care.Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney); removing extra water and waste products and then returning the filtered blood back to the patient | Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions |
Maquet Cardiovascular; LLC | Sep-20-2011 | VASOVIEW 7xB Endoscopic Vessel Harvesting System – VASOVIEW 7xB Endoscopic Vessel Harvesting System;Manufactured by Maquet Cardiovascular; LLC; 170 Baytech Drive; San Jose; CA 95134.Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass. | During routine production quality monitoring process; it was found that UV curing adhesive was not used in a limited number of devices. |
Maquet Cardiovascular; LLC | Sep-20-2011 | VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System – VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System;Manufactured by Maquet Cardiovascular; LLC; 170 Baytech Drive; San Jose; CA 95134.Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass. | During routine production quality monitoring process; it was found that UV curing adhesive was not used in a limited number of devices. |
Maquet Cardiovascular; LLC | Sep-20-2011 | VASOVIEW 6 Endoscopic Vessel Harvesting System – VASOVIEW 6 Endoscopic Vessel Harvesting SystemManufactured by Maquet Cardiovascular; LLC; 170 Baytech Drive; San Jose; CA 95134.Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass. | During routine production quality monitoring process; it was found that UV curing adhesive was not used in a limited number of devices. |
Synthes USA (HQ); Inc. | Sep-21-2011 | Synthes Bone Marrow Aspiration System; Sterile; 11 gauge; 15cm needle (without side holes) – Synthes Bone Marrow Aspiration System; Sterile; 11 gauge; 15cm needle (without side holes)Indicated for aspirating bone marrow | Firm became aware that some systems were released to stock without going through the sterilization process. |
Angiodynamics; Inc. | Sep-23-2011 | NANOKNIFE – ANGIODYNAMICS NANOKNIFE IRE GENERATOR; Catalog/REF No. 20300101; ANGIODYNAMICS; 603 Queensbury Ave.; Queensbury; NY 12804Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue). | Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture. |
Baxter Healthcare Corp. | Sep-23-2011 | Logix Order Entry (OE) Software – LOGIX Order Entry (OE) Software; all versions; catalog 2M8410; Baxter Healthcare; Deerfield; IL 60015; The software is included in a number of Baxter’s pharmacy compounders. The software assists the pharmacist in management of compounding; creating and authorizing nutritional solutions intended for IV administration.Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders. | There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When adding ingredients to a TPN order; the user can accept the pre-populated "per units" of "Bag" or select other "per units". A dosing error may occur if the user does not select the prescribed "per units" for the added ingredient. |
Carl Zeiss Meditec; Inc. | Sep-23-2011 | Zeiss Surgical Microscopes;OPMI¿ Pentero¿; OPMI¿ Vario;OPMI¿ Neuro – OPMI¿ Pentero¿; OPMI¿ Pentero¿ C; OPMI¿ Pentero¿ 900;OPMI¿ Vario/S8; OPMI¿ Vario/S88; OPMI¿ Neuro Multivision/NC4; OPMI¿ Vario/NC33; OPMI¿ Neuro/NC4; OPMI¿ Neuro/NC4 Ceiling Mount.A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area. | Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems. |
Picis Inc. | Sep-23-2011 | CareSuite" – Critical Care Manager; PACU Manager and Anesthesia Manager – CareSuite" – Critical Care Manager; PACU Manager and Anesthesia Manager Software; transmission & storage; patient data.This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources; such as health care professionals; medical devices connected to the system; and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals. | Electronic health record software applications malfunctioned in a manner which failed to display the discontinued status for medication orders; as entered by the attending physician |
Abbott Laboratories; Inc | Sep-26-2011 | Abbott Clinical Chemistry Alkaline Phosphatase Assay – Clinical Chemistry Alkaline Phosphatase; List Number 7D55-21 & 7D55-31.Used for the quantitation of alkaline phosphatase in human serum or plasma. | The reagent has the potential to be contaminated with mold; the Cladosporium fungal species. |
Zimmer Inc. | Sep-27-2011 | Zimmer Trabecular Metal Modular Acetabular System – The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring; a liner; and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty.The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis; avascular necrosis;protrusio acetabuli; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use. | Lot # 61132698; may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically; devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. There has been one reported incident w |
Philips Medical Systems (Cleveland) Inc | Sep-27-2011 | Brilliance CT X-Ray System – Brilliance 64 Computed Tomography System; Model #78231; Serial Number: 9592.The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The firm initiated this action following Philip’s receipt of the customer’s complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the UDMS |
Invacare Corporation | Sep-27-2011 | wheeled adult and junior walkers – Dual Blue-Release Adult Walkers – Wheeled; and Blue Release Junior Walkers with 5 inch Fixed Wheels; Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box.Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking. | The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently; over time; this condition incurs the potential for the caster to loosen and detach; causing the wheels to fall off the walker. This scenario would res |
GE Healthcare; LLC | Sep-27-2011 | ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION – ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTIONGE Medical Systems; SCS.A software module that provides supplemental information to those images extracted from CT and MR temporal datasets. | GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety. |
Hospira Inc. | Sep-29-2011 | 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 softwareThe 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 incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened; and if the clinician has not engaged the clamp prior to opening the cassette door; unrestricted flow may occur. |
Hospira Inc. | Sep-29-2011 | Plum A+ Hyperbaric Single Channel Infusion Pumps – Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira; Inc.; Lake Forest; IL 60045; list 11005.Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened; and if the clinician has not engaged the clamp prior to opening the cassette door; unrestricted flow may occur. | Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened; and if the clinician has not engaged the clamp prior to opening the cassette door; unrestricted flow may occur. |
Hospira Inc. | Sep-29-2011 | 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 – DriverThe 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 incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened; and if the clinician has not engaged the clamp prior to opening the cassette door; unrestricted flow may occur. |