Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
GE Healthcare; LLC Feb-08-2013 Giraffe and Panda Bag and Mask Resuscitation System – Giraffe and Panda Bag and Mask Resuscitation SystemThe T-piece Resuscitation System [ventilator; emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
GE Healthcare; LLC Feb-08-2013 Giraffe and Panda Warmer T-Piece Resuscitation System – GE Healthcare – Giraffe and Panda T-Piece Resuscitation SystemThe T-piece Resuscitation System [ventilator; emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
St Jude Medical Inc Feb-11-2013 AMPLATZER¿ TorqVue¿ FX Delivery System – St. Jude Medical; AGA Medical corporation; AMPLATZER¿ TorqVue¿ FX Delivery System. Model #’s: 9-ITVFX06F45/60; 9-ITVFX07F45/60; 9-ITVFX007F45/80; 9-ITVFX08F45/60; 9-ITVFX08F45/80; 9-ITVFX09F45/80; 9-ITVFX10F45/80 9-ITVFX12F45/80; 9-ITVFX13F45/80. Cardiac surgical instrument; used to close atrial septal defects between the right and left atriums. The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
Lumenis Limited Feb-14-2013 VersaCut Morcellator – The Lumenis VersaCut Tissue MorcellatorProduct Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic; laparoscopic; percutaneous; and open surgical procedures whenever access to the surgical site is limited. Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
DePuy Orthopaedics; Inc. Feb-15-2013 LPS Diaphyseal Sleeves – LPS Diaphyseal SleevesProduct Usage:The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
DePuy Orthopaedics; Inc. Feb-15-2013 LPS Diaphyseal Sleeves – LPS Diaphyseal SleevesProduct Usage:The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
DePuy Orthopaedics; Inc. Feb-15-2013 LPS Diaphyseal Sleeves – LPS Diaphyseal SleevesProduct Usage:The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
DePuy Orthopaedics; Inc. Feb-15-2013 LPS Diaphyseal Sleeves – LPS Diaphyseal SleevesProduct Usage:The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Tobii Assistive Technology; Inc. Feb-01-2013 P10 Tobii battery pack – P10 Tobii battery box (product number 510410)Product Usage – Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system. Tobii ATI customers P10 external battery pack; which contains sealed lead-acid batteries; malfunctioned while recharging and produced smoke with a chemical smell.
Ormco/Sybronendo Feb-01-2013 Lightspeed LSX Files – Sybron Endo Lightspeed: LSX Files; 25MM; Part Numbers: 835-2525; LSX Files; 25MM Assorted Kit; Part Numbers: 835-2455; LSX Files; 30MM; Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. The length markings on the Lightspeed LSX files were wrong.
Philips Healthcare Inc. Feb-01-2013 Phillips Easy Diagnost Elva DRF – Phillips Easy Diagnost Eleva DRF. Model Number: 706034Product Usage:Universal Fluoroscopic Applications The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
Oxus America; Inc. Feb-02-2013 Reliability Plus by Drive – Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC); RS-00400.Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases. Due to past battery inventory storage conditions and deficiencies in the maintenance procedure; it was possible that some batteries were over-discharged to point of damaging the cells.
Synthes USA HQ; Inc. Feb-04-2013 Synthes(R) Spine Vectra; Vectra-T and Vectra-One Adjustable Drill Stop – Synthes(R) Spine Vectra; Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion; Adjustable Drill Stop; Part Number 03.613.012.Synthes Vectra System; Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). Although the reported incidence is low; there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Lansinoh Laboratories Inc Feb-04-2013 THERA PEARL 3-in-1 BREAST THERAPY – THERA PEARL 3-in-1 BREAST THERAPY; 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain; swelling; engorgement; plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump. The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
The Anspach Effort; Inc. Feb-04-2013 Bearing Sleeve with Removable Bur Guard – Anspach Effort; Inc.; 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures. Contactbetween the bur and bur guard could generate metal fragments that may or may not be visible to thesurgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable; design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
Zimmer; Inc. Feb-04-2013 Trilogy F/M Acetabular Shell with Uni-Hole – Trilogy F/M Acetabular Shell with Uni-Hole.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Zimmer; Inc. Feb-04-2013 Trilogy F/M Acetabular Shell without holes – Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM; 40MM; 42MM; 44MM; 46MM; 48MM; 50MM; 52MM; 54MM; 56MM; 58MM; 60MM; 62MM; 64MM; 66MM; 68MM; 70MM.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Zimmer; Inc. Feb-04-2013 Trilogy F/M Acetabular Shell without holes – Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM; 42MM; 44MM; 46MM; 48MM; 50MM; 52MM; 54MM; 56MM; 58MM; 60MM; 62MM; 64MM; 66MM; 68MM; 70MM.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Synthes USA HQ; Inc. Feb-04-2013 Synthes(R) Spine Vectra; Vectra-T and Vectra-One Anterior Cervical Plating – 2.5mm Drill Bit – Synthes(R) Spine Vectra; Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion – 2.5mm Drill Bit; graduated 12mm – 26mm adjustable depth; Part Number 03.613.011.Synthes Vectra System; Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). Although the reported incidence is low; there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Zimmer; Inc. Feb-04-2013 Trilogy Acetabular AB Shells with Holes – Trilogy Acetabular AB Shells with Holes.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Zimmer; Inc. Feb-04-2013 Trilogy Acetabular Shells with Holes – Trilogy Acetabular Shells with Holes.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Zimmer; Inc. Feb-04-2013 Trilogy Acetabular AB Shells with Cluster Holes – Trilogy Acetabular AB Shells with Cluster Holes.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Zimmer; Inc. Feb-04-2013 Trilogy Acetabular Shell with Cluster Holes – Trilogy Acetabular Shell with Cluster Holes.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Zimmer; Inc. Feb-04-2013 Trilogy Acetabular Shell Spiked – Trilogy Acetabular Shell Spiked.The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012; the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Invacare Corporation Feb-04-2013 Solara 3G Custom Manual Wheelchair – Solara 3G Custom Manual WheelchairProduct Usage: To provide mobility to a person restricted to a sitting position. The potential exists for the wheel to rotate freely despite engagement of hub brake.
Winco Mfg.; LLC Feb-04-2013 PREMIER LIFECARE RECLINER 5400 – PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01; 2011 TO AUGUST 20; 2012A multi position recliner with a steel frame used primarily in clinics; hospitals; and treatment centers for recovery; dialysis; oncology; examination; infusion. The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Winco Mfg.; LLC Feb-04-2013 Cozy Comfort Premier Recliner 5580 – Cozy Comfort Premier Recliner 5580WITH CAL TB 133 UPGRADE PURCHASED JAN 01; 2011 TO AUGUST 20; 2012. A multi position recliner with a steel frame used primarily in clinics; hospitals; and treatment centers for recovery; dialysis; oncology; examination; infusion. The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Winco Mfg.; LLC Feb-04-2013 Designer Care Cliner 6700/6704/6710 – Designer Care Cliner 6700/6704/6710WITH CAL TB 133 UPGRADE PURCHASED JAN 01; 2011 TO AUGUST 20; 2012. A multi position recliner with a steel frame used primarily in clinics; hospitals; and treatment centers for recovery; dialysis; oncology; examination; infusion. The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Winco Mfg.; LLC Feb-04-2013 PREMIER CARE RECLINER 5570/5574 – PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01; 2011 TO AUGUST 20; 2012. A multi position recliner with a steel frame used primarily in clinics; hospitals; and treatment centers for recovery; dialysis; oncology; examination; infusion. The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Linvatec Corp. dba ConMed Linvatec Feb-05-2013 PopLok Punch 3.5MM – ConMed Linvatec Biomaterials; PopLok bone Punch PKL-35M; 3.5mm Orthopedic manual surgical instrument – Bone Punch ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
Exactech; Inc. Feb-05-2013 Novation Crown Cup Connection GXL Neutral Liners – Exactech NOVATION CROWN CUP; NEUTRAL LINER; Use with Crown Cup Only; GXL UHMWPE; SN 0123456; REF 130-32-53.Exactech Hip Systems are indicated for use in surgery for hip replacement. Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
Exactech; Inc. Feb-05-2013 NOVATION CROWN CUP +5mm LATERALIZED LINER – Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER; Use with Crown Cup Only; GXL UHMWPE; SN 0123456; REF 136-32-53.Exactech Hip Systems are indicated for use in surgery for hip replacement. Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
Remel Inc Feb-06-2013 Oxoid Antimicrobial Susceptibility Test Discs – Oxoid Antimicrobial Susceptibility Test Discs; Aztreonam 30 ug; IVD; REF CT0264B; Oxoid Ltd.; UK; oxoid@thrmofisher.com (Both Remel & Oxoid; Ltd are a part of Thermo Fisher Scientific)An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure; by a disc-agar diffusion technique or a disc-broth elution technique; the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam). The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.
Allergen Medical Feb-07-2013 Allergan SeriScaffold Surgical Scaffold – SeriScaffold Surgical ScaffoldProduct Number: SCF10X25AGEN.Surgical mesh for use in open or laparoscopic procedures. Product is dual packaged in an inner and outer pouch; the outer pouch seal may be compromised and sterility may not be assured
Custom Healthcare Systems; Inc. Feb-07-2013 Breast Biopsy tray – Custom Breast Biopsy Tray; Catalog # B 9-16261; packaged in bags; 1 tray/bag; 20 bags/case.Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Custom Healthcare Systems; Inc. Feb-07-2013 Breast Biopsy Kit – Custom Breast Biopsy Tray w/Sodium Chloride; Catalog # B9-15263A; packaged in bags; 1 tray/bag; 20 bags/case.Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Medacta Usa Inc Feb-07-2013 Quadra Trial Broach size 0 – Medacta Quadra Trial Broach size 0 part # 01.10.10.045; for use with the Medacta Total Hip Prosthesis System. Product Usage – used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery. The tip of the Quadra Trial Broach size 0; broke during a surgery.
Bacterin International; Inc. Feb-11-2013 Osteoselect Demineralized Bone Matrix DMB Putty – Bacterin International; Inc.; Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. Expired product was shipped to two customers.
Mindray DS USA; Inc. d.b.a. Mindray North America Feb-11-2013 DPM Central Monitoring System – Mindray DS USA; Inc.; DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002; and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01; -03; -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices. Mindray has identified a software anomaly that may where; in the presence of an asystole; the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
Fresenius Medical Care Holdings; Inc. Feb-11-2013 Fresenius Liberty Cycler Set Single Conn. Ext. DL. – Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.Acute and chronic peritoneal dialysis. There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured; the dialysate may become contaminated potentially resulting in peritonitis.
Remel Inc Feb-11-2013 Legionella BCYE Growth Supplement SR0110C – The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCVE Medium used for isolation of Legionellae from clinical and environmental samples. The product may contain low level microbial contamination which could result in incorrect results.
Remel Inc Feb-12-2013 Remel X/pect Clostridium Difficile Toxin A/B (20 tests) – Remel Xpect Clostridium difficile Toxin A/B; IVD; 20 clostridium difficile toxin A/B tests; REF 24650.Product Usage: Usage:The test kit is a rapid in vitro immunochromatographic test for the direct; qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease. The firm is recalling the products due to a potential for false negative test results.
Remel Inc Feb-12-2013 Remel X/pect Clostridium Difficile Toxin A/B (40 tests) – Remel Xpect Clostridium difficile Toxin A/B; IVD; 40 clostridium difficile toxin A/B tests; REF 24640.Product Usage:The test kit is a rapid in vitro immunochromatographic test for the direct; qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease. The firm is recalling the products due to a potential for false negative test results.
Breg Inc; An Orthofix Company Feb-12-2013 BREG Cold Therapy Combination Units – BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M; PAD M/U XL STER; Mfg.Date: 112012. Model #s: 10903; 10703; 09101; 09111; 09131; 09731; 09611; 09621; and 09631. Local anesthetic effect. The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Breg Inc; An Orthofix Company Feb-12-2013 BREG Sterile Polar Pads – BREG Sterile Polar Pads; 02356 Rev M; PAD M/U XL STER; Mfg.Date: 112012. Model #s: 02510; 09901; 02330; 02350; 02490; 02356; 02496; 02410. Local anesthetic effect. The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Aesculap; Inc. Feb-12-2013 Aesculap(R) – Miethke Shunt System – Aesculap(R) – Miethke Shunt System; FT040T – Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet; w/Stylet & RT-ANG GuideCentral Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter
Remel Inc Feb-12-2013 Oxoid Antimicrobial Susceptibility Discs FOX30; Cefoxitin – Oxoid Antimicrobial Susceptibility Discs; Cefoxitin 30ug REF CT0119B; packaged with 50 discs per cartridge; 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd.; Basingstoke; Hants; UK. The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Terumo Cardiovascular Systems Corporation Feb-12-2013 CDI 101 Hematocrit/Oxygen Saturation Monitoring System – Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation; hematocrit and hemoglobin levels. Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
GE Healthcare; LLC Feb-13-2013 Dash 3000; Dash 4000 and Dash 5000 Monitor and accessories. – GE Healthcare; Dash 3000; Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m
CHENICA INC. Feb-13-2013 Rehab Tough and Tilt (TNT); Rehab Recline and Mobility (RAM); Rehab Kidster (Kidster) – Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair; Sold as Rehab Tough and Tilt (TNT); Rehab Recline and Mobility (RAM); Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position. The wheelchairs may not meet the specifications of WC-19 (crash testing); therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).
Mizuho OSI Feb-13-2013 Mizuho Orthopedic Systems; Inc. – Mizuho Orthopedic Table; model 5855; sub assembly 5855-901 Orthopedic Table Spar. Possible instability of Orthopedic Table Top. If the epoxy bond fails; the aluminum plug may migrate out of the carbon fiber tube. If this occurs; the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.
Lockheed Martin Gyrocam Systems; Inc. Feb-14-2013 Lockheed Martin Gyrocam Systems ( LMGS – Lockheed Martin Gyrocam Systems ( LMGS)LMGS 15" camera systems Laser pointer and illuminator used for law enforcement surveillance from aircraft. These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying; leveling; and alignment lasers and were entered into US commerce without a variance. Additionally; the manufacturer did not submit a product report to FDA for the camera system.
GE Healthcare; LLC Feb-14-2013 GE Healthcare; CARESCAPE Monitor B650 – GE Healthcare; CARESCAPE Monitor B650.The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
Quidel Corporation Feb-14-2013 Sofia Influenza A + B FIA; Kit #20218 – Quidel; Sofia Influenza A + B FIA; Kit #20218 (25-Test Kit); in vitro diagnostic. Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
GE Healthcare; LLC Feb-14-2013 GE Healthcarr – Dash Port 2 Docking Station – GE Healthcare; Dash Port 2 Docking Station.Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult; pediatric; and neonatal patients. GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2monitor. This report of correction encompasses the DashPort 2 device; in which the DashPort 2 stopscommunicating with the Dash; resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDsin the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
Philips Healthcare Inc. Feb-14-2013 Philips Healthcare SureSigns VS2+ – Philips Healthcare SureSigns VS2+Model 863278 SureSigns VS2+ NBP and SpO2Model 863279 SureSigns VS2+ NBP; SpO2 and TemperatureProduct Usage:The SureSigns VS2+ vital signs monitor is for monitoring; recording and alarming of multiple physiological parameters of adults; pediatrics; and neonates in healthcare environments. Additionally; the monitor is intended for use in transport situations within a healthcare facility. VS2+ screen may lock up and stop monitoring during patient use
Viterion TeleHealthcare Llc Feb-14-2013 Viterion V100 Telehealth Monitors – Viterion TeleHealth Monitor Model Number V100; Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100; V100-BGM and V500 Telehealth Monitors transfer medical information. Viterion telehealth monitors do not transmit "HI" (above the meter’s measurable range) and "LO" (below the meter’s measurable range) blood glucose readings from Bayer’s Contour Elite XL blood glucose meters; or from Roche’s Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Viterion TeleHealthcare Llc Feb-14-2013 Viterion V100-BGM Telehealth Monitors – Viterion TeleHealth Monitor Model Number V100-BGM; Product Code 81842478 (US) — Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100; V100-BGM and V500 Telehealth Monitors transfer medical information. Viterion telehealth monitors do not transmit "HI" (above the meter’s measurable range) and "LO" (below the meter’s measurable range) blood glucose readings from Bayer’s Contour Elite XL blood glucose meters; or from Roche’s Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Viterion TeleHealthcare Llc Feb-14-2013 Viterion V500 Telehealth Monitors – Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) – Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100; V100-BGM and V500 Telehealth Monitors transfer medical information. Viterion telehealth monitors do not transmit "HI" (above the meter’s measurable range) and "LO" (below the meter’s measurable range) blood glucose readings from Bayer’s Contour Elite XL blood glucose meters; or from Roche’s Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
NAImco Inc dba Richmar Inc Feb-14-2013 Foam Electrodes with Silver-Carbon construction – Foam electrodes with Silver-Carbon construction:P/N 202-9271; Cat No. 400-898; 2" x 2" Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9281; Cat No. 202-9281; 2" Round Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9251; Cat No. 400-893; 3" Round Electrode; Foam AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9291; Cat No. 400-892; 3" Round Electrode; Foam AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9371; Cat No. 400-888; 2" x 3.5" Electrode; Foam AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9491; Cat No. 400-869; 1.25" Round Electrode; Foam AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9511; Cat No. 400-853; 3" x 5" Electrode; Foam AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 300-1541; Cat No. 300-154; 2" x 2.25" Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 300-1561; Cat No. 300-156; 2" Round Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 300-1611; Cat No. 300-161; 4" x 2.25" Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010; 22818P/N 300-1631; Cat No. 300-163; 3" Round Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 400-8701; Cat No. 400-870; 2" x 4" Oval Electrode; Foam; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010.Cutaneous electrode. Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
NAImco Inc dba Richmar Inc Feb-14-2013 Cloth electrodes with Silver-Carbon construction – Cloth electrodes with Silver-Carbon construction:P/N 202-9231; Cat No. 400-899; 2" x 2" Electrode; Cloth; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9241; Cat No. 400-895; 2" Round Electrode; Cloth; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9381; Cat No. 400-889; 2" x 3.5" Electrode; Cloth AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-9501; Cat No. 202-9501; 1.25" Round Electrode; Cloth AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 400-8991; Cat Nos.: 400-877T and 400-899T; 2" x 2.25" Electrode; Cloth; AG; All Serial Numbers distributed between 11/01/2009 and 01/31/2010.Cutaneous electrode. Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
NAImco Inc dba Richmar Inc Feb-14-2013 Cloth electrodes with Carbon construction – Cloth electrodes with Carbon construction: P/N 201-1231; Cat Nos.: 201-123; 202-454; 203-118; 203-342; 203-454; 203-493; 203-672; 400-877; and 400-877-BJC; 2" x 2" Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241; Cat Nos.: 201-124; 202-455; 203-340; 203-674; and 400-872; 2" Round Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1251; Cat Nos.: 201-138; 202-276; 202-456; 203-336; 203-680; and 400-879; 3" Round Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1381; Cat Nos.: 201-126; 203-678; and 400-856; 2" x 3.5" Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1501; Cat Nos.: 201-150 and 400-863; 1.25" Round Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1521; Cat No. 400-852; 3 x 5 Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1541; Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode; Cloth; All Serial Numbers distributed between 11/01/2009 and 01/31/2010Cutaneous electrode. Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
NAImco Inc dba Richmar Inc Feb-14-2013 Foam Electrodes with Carbon construction – Foam Electrodes with Carbon construction:P/N 201-1261; Cat Nos.: 201-126; 203-678; and 400-856; 1.5" x 3.5" Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1271; Cat Nos.: 201-127; 202-093; 203-483; 203-565; 203-673; and 400-873; 2" x 2" Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1281; Cat Nos.: 201-128; 202-277; 203-675; and 400-873; 2" Round Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1291; Cat Nos.: 201-129; 203-677; and 400-882; 3" Round Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1301; Cat Nos.: 201-130; 203-679; and 400-855; 1.5" x 3.5" Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 201-1371; Cat Nos.: 201-137; 202-278; 203-484; 203-681; and 400-880; 2" x 3.5" Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010P/N 202-5671; Cat No. 202-567; 2" x 2" Electrode; Foam; All Serial Numbers distributed between 11/01/2009 and 01/31/2010.Cutaneous electrode. Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
ConMed Corporation Feb-15-2013 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES – BLUNT – ELECTROLASE(R) HYFRECATOR(R) ELECTRODES – BLUNT; REF/Catalog Number 7-101-8BX; Disposable Hyfrecator(R) Tips; Sterile; Rx Only — CONMED CORPORATION USA.Intended to be used as active RF electrodes for desiccation; fulguration and coagulation. Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
ConMed Corporation Feb-15-2013 ELECTROLASE HYFRECATOR(R) ELECTRODES – SHARP – ELECTROLASE HYFRECATOR(R) ELECTRODES – SHARP; REF/Catalog Number 7-100-8BX; Disposable Hyfrecator(R) Tips; Sterile; Rx Only — CONMED CORPORATION USA.Intended to be used as active RF electrodes for desiccation; fulguration and coagulation. Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Greiner Bio-One North America; Inc. Feb-15-2013 VACUETTE Safety Blood Collection Set + Luer Adapter – VACUETTE Safety Blood Collection Set + Luer Adapter; 23×12" Safety Blood Collect LA Product; Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures. The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Healthtronics; Inc. Feb-15-2013 HealthTronics Endocare 3.8mm RenalCryo Cryoprobe – HealthTronics Endocare 3.8mm RenalCryo Cryoprobe; R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System; for freezing and ablation of tissue. The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
Carefusion 303 Inc Feb-15-2013 CareFusion SmartSite Gravity Blood Set – CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient’s artery or vein. CareFusion is recalling the SmartSite? Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs; this could cause a delay in treatment.
International Technidyne Corp. Feb-19-2013 Pro Time Microcoagulation System/ Pro Time 3 Cuvette – Pro Time Microcoagulation System/ Pro Time 3 Cuvette; Pro3-4; Pro3-25; and Pro3-50.International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood. Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.
Varian Medical Systems; Inc. Oncology Systems Feb-20-2013 Eclipse Treatment Planning System – Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition; the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where the calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
Stryker Sustainability Solutions Feb-20-2013 Restep DVT System – STRYKER Sustainability Solutions; AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System; an external compression system. PUMPKIT (Pump Kit); and RSP159-01 (AC Power Adaptor). Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Merit Medical Systems; Inc. Feb-20-2013 ReSolve – Merit Medical Systems Inc.; Resolve Biliary Locking Drainage Catheter; Models RBC and RBDC; used for drainage of bile within the biliary system. Merit Medical Systems is recalling certain lots of ReSolve Biliary Locking Drainage Catheters due to a consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Vascular Solutions; Inc. Feb-20-2013 Percutaneous Catheter – Vascular Solutions; SuperCross Microcatheter; Sterilized using ethylene oxide; Rx Only; Model numbers 5300 – 5307; 5324; 5325; 5329; 5332; 5336; 5340; and 5341.Product Usage:The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents Vascular Solutions; Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
Maquet Cardiovascular Us Sales; Llc Feb-20-2013 ELS Cannula 15 FR – Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants. ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
Ansell Healthcare Products LLC Feb-20-2013 Zero – LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC; Dothan; AL 96303.A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). Out of an abundance of caution; Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However; we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage; and so we are asking to have all products returned.
Elekta; Inc. Feb-20-2013 Monaco RTP System – Monaco RTP System.Radiation treatment planning. The beam is displayed at the "gantry" angle; but the dose is calculated at the "rotation_start" angle.
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx90 GUIDING CATH MPCProduct Code: GMC60900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of packaging integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx90 GUIDING CATH S2Product Code: GSM50900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx90 GUIDING CATH HHProduct Code: GHH60900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx100 GUIDING CATH HHProduct Code: GHH51000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx100 GUIDING CATH HHProduct Code: GMC51000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH MPDProduct Code: GMD60900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx100 GUIDING CATH MPProduct Code:GMD51000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH STProduct Code: GST61000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx100 GUIDING CATH S2Product Code: GSM51000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH MCProduct Code: GCB61000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH S2Product Code: GSM61000000 Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx100 GUIDING CATH MCProduct Code: GCB51000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx90 GUIDING CATH MCVProduct Code: GCB50900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx90 GUIDING CATH MPCProduct Code: GMC50900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH MPProduct Code: GMD61000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx90 GUIDING CATH MPDProduct Code: GMD50900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx100 GUIDING CATH STProduct Code: GST51000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx90 GUIDING CATH STProduct Code: GST50900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx90 GUIDING CATH STProduct Code: GST60900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 5Fx90 GUIDING CATH HHProduct Code: GHH50900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx90 GUIDING CATH MCVProduct Code: GCB60900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx90 GUIDING CATH S2Product Code: GSM60900000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH HHProduct Code: GHH61000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Codman & Shurtleff; Inc. Feb-20-2013 Codman (and Formerly MICRUS) NEUROPATH – NEUROPATH 6Fx100 GUIDING CATH MPProduct Code: GMC61000000Intended for use in the coronary; peripheral; and neurovasculature for intravascular introduction of interventional/diagnostic devices Sterility of device may be compromised due to lack of package integrity
Integra LifeSciences Corp. Feb-21-2013 MAYFIELD¿ Composite Series Base Unit Standard – MAYFIELD¿ Composite Series Base Unit Standard; Model (A3101); Rx ONLY; Integra LifeScience Corporation; 4900 Charlemar Drive; Building A; Cincinnati; OH 45227The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest; or skull clamp is necessary; positional freedom is required and where X-ray imaging modalities will be used. Integra determined there is a possibility that the Base Units may break during use.
Philips Healthcare Inc. Feb-21-2013 Philips HeartStart XL+ Defibrillator/Monitor – Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced life support or defibrillation Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use
Hill-Rom; Inc. Feb-21-2013 Overhead Rail System – Liko Overhead Rail System; Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall; Multirall and Masterlift SystemsProduct Usage – The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts. Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con
Medrad Inc Feb-21-2013 MEDRAD(R) Hand Controller Sheath – MEDRAD Hand Controller Sheath; Catalog number AVA 500 HCS/3010903; for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients. Bayer is initiating this recall because in certain packages within the affected lots; the seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package; resulting in a potential breach of the sterility of this accessory.
Mc-NEIL-PPC; Inc. Feb-22-2013 KY¿ SENSITIVETM JELLY – KY¿¿ SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes; which are then packed into a printed carton. U.S.A.: Distributed by/Distribue par: McNeil-PPC Inc.; Skillman; NJ 08558-9418. Canada: Johnson & Johnson Inc.; Markham; Canada; L3R5L2Personal lubricant. JJHP is voluntarily recalling this product based on a retrospective review of the Design History File that indicated a separate medical device clearance application is required. New data to support regulatory clearance would be required to support a510(k) filing. The company made a decision to not remediate the file and generate the data therefore the company has decided to initiate a Class II
Mc-NEIL-PPC; Inc. Feb-22-2013 KY¿ TINGLING¿ JELLY Personal Lubricant. – KY¿ TINGLING¿ JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. U.S.A.: Distributed By: McNeil-PPC Inc.; Skillman; NJ 08558-9418. Made in Canada.Personal lubricant. JJHP is voluntarily recalling this product based on a retrospective review of the Design History File that indicated a separate medical device clearance application is required. New data to support regulatory clearance would be required to support a510(k) filing. The company made a decision to not remediate the file and generate the data therefore the company has decided to initiate a Class II
Mc-NEIL-PPC; Inc. Feb-22-2013 KY¿ SilkE¿ Vaginal Moisturizer and Personal Lubricant – KY¿ SilkE¿ Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles; which are then packed into a printedcarton. U.S.A.: Distributed by/Distribue par: McNeil-PPC Inc.; Skillman; NJ 08558-9418. Canada: Johnson & Johnson Inc.; Markham; Canada; L3R5L2.Personal lubricant. JJHP is voluntarily recalling this product based on a retrospective review of the Design History File that indicated a separate medical device clearance application is required. New data to support regulatory clearance would be required to support a510(k) filing. The company made a decision to not remediate the file and generate the data therefore the company has decided to initiate a Class II
Intel-GE Care Innovations LLC Feb-23-2013 Care Innovations QuietCare-Networked product – QuietCare-Networked product; Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements. Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated; a defect in the implementation of the Wander and Night Motion ADLs was discovered.
Medacta Usa Inc Feb-23-2013 Versafitcup Total Hip System-Impacting Ring – Versafitcup Impacting RingModel Number: 01.26.10.0133 (46mm); 01.26.10.0134 (48mm); 01.26.10.0135 (50mm); 01.26.10.0136 (52mm); 01.26.10.0137 (54mm); 01.26.10.0138 (56mm); 01.26.10.0139 (58mm); 01.26.10.0140 (60mm); 01.26.10.0141 (62mm); 01.26.10.0142 (64mm).Designed for cementless use in total hip arthroplasty. Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia; having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
Cellestis Inc Feb-26-2013 QuantiFERON – TB Gold TB High Altitude (HA)Blood Collection Tubes – Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13×75 50pcs.;1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6; CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood. Cellestis is recalling QuantiFERON?? – TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Cellestis Inc Feb-26-2013 QuantiFERON – TB Gold TB High Altitude (HA)Blood Collection Tubes – VACUETTE Cellestis 1 ml QuantiFERON¿ – TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.;1200 pcs. in total;Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6; CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood. Cellestis is recalling QuantiFERON?? – TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Elekta; Inc. Feb-26-2013 Apex Add-on microMLC – ApexIt is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues. If the Apex collimator is incorrectly installed on the radiation head; a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
Aesculap; Inc. Feb-26-2013 Aesculap(R) Bipolar Coagulator/Foot Pedal – Aesculap Bipolar Generator Foot Pedal; Catalog No. GK226Product Usage: Aesculaps Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery; ENT surgery; urology; laparoscopy; and plastic surgery. AIC (USA) received a notification from Aesculap; AG (the manufacturer) regarding complaints that the bipolar energy did not stop after release of the foot pedal.
Philips Medical Systems (Cleveland) Inc Feb-26-2013 GEMINI Big Bore PET & X-Ray CT scanning systems – GEMINI TF Big Bore; Model #882476; Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system; 510(k) #K081135.The GEMINI Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are ‘flipped’ and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Philips Medical Systems (Cleveland) Inc Feb-26-2013 GEMINI LXL; TF 16 and TF64; PET & X-Ray CT scanning systems – GEMINI LXL – Model #882412; GEMINI TF 16 – Model #882470 and Model #882473; GEMINI TF 64 – Model #882471; Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems; 510(k) #K052640.The GEMINI TFI 6; TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are ‘flipped’ and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Philips Medical Systems (Cleveland) Inc Feb-26-2013 Brilliance Big Bore and Brilliance Big Bore Oncology CT X-Ray Scanners – Brilliance Computed Tomography (CT) X-Ray Scanners; Big Bore; Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners; Big Bore Oncology; Model #728244; 510(k) #K033357.The Brilliance CT Big Bore is a Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include display equipment; signal analysis; as well as patient and equipment supports; components and accessories. Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are ‘flipped’ and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Philips Medical Systems (Cleveland) Inc Feb-26-2013 Brilliance Big Bore and Brilliance Big Bore Oncology CT X-Ray Scanners – Extended Brilliance Workspace (EBW) X-Ray Scanners; Model #728260; 510(k) #K012009.The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; as well as patient and equipment supports; components and accessories. Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are ‘flipped’ and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Philips Medical Systems (Cleveland) Inc Feb-26-2013 Mx8000 IDT Whole Body Computed Tomography X-ray system – Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems; Highland Heights; OH 44143The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices;which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Integra LifeSciences Corp. Feb-26-2013 Integra(R) Jarit(R) Monopolar Cable – Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290)Product Usage: Endoscopic Instruments – For use by; or as directed by; a surgeon in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar Cable – Monopolar electrosurgical current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon. Integra has received complaint reports related to the electrical safety of the monopolar electrosurgical cables.
Baylis Medical Company Inc. Feb-26-2013 BMC RF Cannula – BMC RF Cannula Curved Sharp RadiOpaque; Non-Pyrogenic; Active Tip: 10mm; Gauge 16 Ga; Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain. A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse; the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients; as the unsealed packages
Oculus Innovative Sciences Inc Feb-26-2013 Atrapro Antipruritic Hydrogel; 1.5 oz gel tube – Atrapro Antipruritic Hydrogel; 1.5 oz gel tube; 4 Net wt/ 1.5 oz..RX only; Professional Sample; Not for Sale.Pre-printed tube: MS31071;Shelf carton: PL51091-08Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning; itching and pain experienced with various types of dermatoses; including radiation dermatitis and atopic dermatitis. Out of specification result – stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.
Philips Healthcare Inc. Feb-26-2013 Philips Digital Diagnost – Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3Model numbers 712020; 712022; and 712082Product Usage: Digital radiographic system When the operator for a wall stand view selects an "image rotation" different from default; or such image rotation is preset in the examination database; then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back; electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
GE Healthcare; LLC Feb-26-2013 GE Healthcare Brivo XR385 DR-F/ X-Ray System – GE Healthcare Brivo XR385 DR-F/ X-Ray SystemX-Ray System GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Myco Medical Supplies Inc Feb-27-2013 Technocut Plus;Sterile Single Use Safety Scalpel. – Technocut Plus;Sterile Single Use Safety Scalpel; Distributed by: Myco Medial Cary; NC 27513. The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical; pathology; and minor medical procedures. Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
GE Healthcare; LLC Feb-27-2013 GE Healthcare Definium 5000 – GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull; spinal column; chest; extremities; abdomen and other body parts. It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.
GE Healthcare; LLC Feb-27-2013 GE Healthcare Definium 5000 – GE Healthcare Definium 5000/5220493-2 X-Ray System .This expected use for this product is intended to take diagnostic radiographic exposures of the skull; spinal column; chest; extremities; abdomen and other body parts. It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.
