Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Fisher & Paykel Healthcare; Ltd. Jan-03-2013 900MR068 Reusable Circuits – Fisher & Paykel Healthcare reusable breathing circuit.Non-heated breathing circuit; 1.8m or 6 feet in length.Oxygen therapy delivery system for adult patient. FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use; it could potentially result in a gas leak in the breathing system; which may lead to a loss of pressure for the int
Vycor Medical; Inc. Jan-17-2013 Vycor Medical ViewSite Brain Access System – Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***Product Usage:The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue; visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Bausch and Lomb; Incorporated Jan-17-2013 Bausch & Lomb Disposable 27G cannula – Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051; 59081; 59051L; 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081; 60051; 60051L; 60081L) ophthalmic viscosurgical device.The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures. Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents; detachment has resulted in serious patient injury.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Recalling Manufacturer Date Posted Trade Name/Product Reason for Recall
Envoy Medical Corporation Jan-30-2013 Esteem Programmers – Esteem Programmers part of the Esteem Totally Implantable Hearing SystemWorldwide Distribution-USA including the states of AL; AZ; CA; CT; FL; GA; IL; MA; MI; MN; NC; OK; RI; and TX; and the country of GERMANY.This correction applies to the Esteem Programmer Model 6001; US and ISA; Model 3001 Dell E54XX.The ISA and Commander are software packages that run on a laptop personal computer. A laptop can be configured to carry both or either one of the ISA and Commander functionality with separate boot records for each application. In the operative suite; the ISA is used to support implants. All ISA units will also carry Commander. in an Audiologist’s or Surgeon’s office; the Commander is used to support fittings of the device. The ISA functionality will not usually be present. The Correction applies to the use of the Commander therefore all ISA units will also be subject to this Correction. Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers; part of the Esteem Totally Implantable Hearing System; to reduce their susceptibility to noise interference.
Biomet; Inc. Jan-30-2013 Arthrotek Interference Screw – TUNNELOC ROUND HEAD INTERFERENCE SCREW8MMX25MMBiomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation; due to injury or degenerative disease. Implants used for this application include: screws; washers; anchors; pins; and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction. Thru hole at the tip of the screw is undersized.
Extremity Medical LLC Jan-30-2013 Extremity Medical LLC – IO FiX System AccessoryExtremity Medical; LLC300 Interpace Parkway; Suite 410Parsippany; NJ 07054 USAThis screw measuring device is an accessory to the IO FiX Screw and Washer System (PMA reference #K101700 and K121347) that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
Greatbatch Medical Jan-30-2013 45¿ Angle Driver – 45¿ Angle Driver / Z-H; Greatbatch Medical 10 000 Wahrie Drive; Clarance; NY 14031.Model #: P2661; P2662; T3635; T5586;T6031; T6164;T10161; T12628;T14879; T16422;T2487;T2713;T116057; T13635; MPU260045AO01; MPU260045ZH01.The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill). Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45? product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
Ortho-Clinical Diagnostics Jan-30-2013 VITROS¿ Chemistry Products Vapor Adsorption Cartridge – Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600; VITROS¿ 5600; and VITROS¿ ECi/ECiQ Systems. Some VITROS? Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances; the Particulate Cartridge has been inadvertently installed on the VITROS? System instead of the intended VITROS? Vapor Adsorption Cartridge which may bias results.
Motorola Inc Jan-30-2013 Motorola Solutions Laser – Motorola Solutions PCS3000/CS3070 LaserUtility/Peripheral Laser Products It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
GE Healthcare; LLC Jan-30-2013 AdvantageSim MD – AdvantageSim MD versions 7.4 through 7.6; Model 5160092-2 Version 7.4; 5160092-3 Version 7.5; 5160092-4 version 7.6. It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation; the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
Alfa Wassermann; Inc. Jan-28-2013 Alfa Wassermann System Diluent 750 mL – Alfa Wassermann System Diluent 750 mLManufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell; NJ 07006Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK; Woerden The NetherlandsCommon name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument. Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Carestream Health; Inc. Jan-28-2013 KODAK – KODAK INSIGHT DENTAL FILM in SureSoft Packets; Size 2 Single Packet Film; Model Number IP21S; REF/Catalog Number 8118226 — COMMON/USUAL NAME: Dental Intraoral Radiographic Film — 20 cartons of 80 packets.Product Usage:Dental intraoral radiography The company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number 8118226 have missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol; name and address including country of
Philips Healthcare Inc. Jan-28-2013 Juno – Juno DRF ; X-ray system; diagnostic; Fluoroscopic; general-purposeModel: 70920Product Usage:Universal R/F; general use Values of fluoroscopy time; Air Kerma Rate andCumulated Air Kerma may not be displayed "atthe fluoroscopist’s working position" as per 21 CFR 1003.21
Mindray DS USA; Inc. d.b.a. Mindray North America Jan-27-2013 Mindray DS USA Inc. – DPM5 MonitorProduct Usage:A vital signs monitor used on human patients. The target populations are adult; pediatric; and neonatal patients. The DPM5 Monitor has many features and functions; yet is easy to use through an integrated keypad; knob and intuitive menu system. The patient parameters that can be monitored by DPM5 monitors are ECG (3- lead or 5-lead selectable); Heart Rate (HR); Pulse Rate(PR); Respiration Rate (RESP); Non-invasive Blood Pressure (NIBP) ; Saturation of Pulse Oxygen (SpO2); Temperature (TEMP); Invasive Blood Pressure (IBP); Carbon Dioxide (CO); Anesthetic Gases (AG) . Its design allows the operator to adjust the setting of parameter alarms that audibly and visually notify the operator when an excursion occurs. The DPM5 monitor is intended for use in health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment. The DPM5 monitor is not recommended for use in a patients home or resident; or when it has not been ordered by a physician.Pr Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Becton Dickinson & Co. Jan-25-2013 BBL(TM) Fildes Enrichment – BBL(TM) Fildes Enrichment; catalog number 211866; 10 tubes/pack; labeled in part ***Becton Dickinson and Company; Sparks; MD 21152 USA***Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms; including the X (hemin) and V (nicotinamide adenine dinucleotide; NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use. Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
bioMerieux; Inc. Jan-25-2013 BacT/ALERT SA Blood Culture Bottle – BacT/ALERT SA Blood Culture Bottle.The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Cordis Corporation Jan-25-2013 Cordis ExoSeal Vascular Closure Device – Cordis***a Johnson & Johnson Company***Cordis***ExoSeal(TM)***6F***Vascular Closure Device***REF cat. No EX600***LOT No. LOTNR***Use by UBD***STERILE R***Sterilized with Irradiation *** Attention; see Instructions for Use.***DO NOT RESTERILIZE***For one use only.***Do not use open or damaged packages.***Store in a cool; dark; dry place. ***Nonpyrogenic***LBEX6001.4***JOBNR***Assembled in Mexico***Cordis***Cordis ExoSeal (TM) EX600***6F***LOT***LOTNR***+H739EX60023***SEC.BARCODE***Cordis Corporation***14201 North West 60th Avenue***Miami Lakes; Florida 33014***USA.The Cordis ExoSeal (TM) VCD is indicated for femoral artery puncture site closure; reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures. On 10/29/2012 Cordis Corporation; Miami Lakes; FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500; EX600; and EX700.
Medisystems a NX Stage Company Jan-24-2013 Medisytems – Medisystems 17 Gauge x 1" inch AV Fistula NeedleProduct Code: D9-2007MGLBProduct Usage:Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector Single needle packs in each case ( 10 needlesper case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
Medisystems a NX Stage Company Jan-24-2013 Buttonhole Needle Set – Medisystems 15 Gauge x 3/5 inch Buttonhole Needle SetProduct Code: BH-2035PEProduct Usage:Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion. A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
ConMed Corporation Jan-24-2013 Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade; – Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade; REF/Catalog No. 60-7524-001; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 4 inch Coated Blade – UltraClean(R) Accessory Electrode 4 inch Coated Blade; REF/Catalog No. 139112; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation – UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation; REF/Catalog No. 139110EXT; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation – UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation; REF/Catalog No. 139108; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 6 inch Coated Blade – UltraClean(R) Accessory Electrode 6 inch Coated Blade; REF/Catalog No. 139107; Single Use; Sterile; Rx ONLY — CONMED CORPORATION; Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation – UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation; REF/Catalog No. 139105EXT; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation – UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation; REF/Catalog No. 139104EXT; Single Use; Sterile; Rx ONLY — CONMED CORPORATION 525 Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 1 inch Coated Needle – UltraClean(R) Accessory Electrode 1 inch Coated Needle; REF/Catalog No. 139102; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode – UltraClean(R) Accessory Electrode; 1 inch Coated Blade; REF/Catalog No. 139100; Single Use; Sterile; Rx ONLY –CONMED CORPORATION; Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 Electrosurgical Tip Cleaner – Electrosurgical Tip Cleaner; REF/Catalog No. 138029; Single Use; Sterile; Rx ONLY — Distributed By: CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 ELECTROSURGICAL ENT NEEDLE ELECTRODE – ELECTROSURGICAL ENT NEEDLE ELECTRODE; 6 inch with Extended Insulation; REF/Catalog No. 138025; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES – SHARP – ELECTROLASE(R) HYFRECATOR(R) ELECTRODES – SHARP; Disposable Hyfrecator(R) Tips; REF/Catalog No. 7-100-8CS; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES – BLUNT – ELECTROLASE(R) HYFRECATOR(R) ELECTRODES – BLUNT; Disposable Hyfrecator(R) Tips; REF/Catalog No. 7-101-8CS; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation – Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation; REF/Catalog No. 60-7521-001; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation; – Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation; REF/Catalog No. 60-7523-001; Sterile; Rx ONLY — CONMED CORPORATION; Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation – UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation; REF/Catalog No. 139112EXT; Single Use; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade; – Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade; REF/Catalog No. 60-7526-001; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 ABC(R) NOZZLE – ABC(R) NOZZLE; Single Patient Use Nozzle; (For use with 130500 Reusable ABC(R) Handpiece); REF/Catalog No. 130343; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 TUR/Endoscopic Cable – TUR/Endoscopic Cable; 10 feet (3.05 mm); REF/Catalog No. 135171; Disposable; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed Corporation Jan-24-2013 CONMED(R) ELECTROSURGICAL SAFETY HOLSTER – CONMED(R) ELECTROSURGICAL SAFETY HOLSTER; Disposable Safety Holster; REF/Catalog No. 137668; Sterile; Rx ONLY — CONMED CORPORATION Electrosurgical; Cutting and Coagulation and Accessories. ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
Ansell Healthcare Products LLC Jan-24-2013 LifeStyles Pleasure Collection Condoms – Lifestyles Pleasure Collection 30 Premium Lubricated CondomsAssortment of Ultra Sensitive; Flavors and Colors; Skyn; Thryll; Thyn; and Ultra Thin. UPC 0-70907-02625-0. One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
Abbott Point of Care Canada Limited Jan-24-2013 Abbott Point of Care i-Stat cTnI cartridge – Abbott Point of Care i-Stat cTnI cartridge.The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality. APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 10X100MM TlProduct Code: 1867-15-199 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head.
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 8 X100MM TlProduct Code: 1867-15-899 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM TlProduct Code: 1867-15-170 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 9 X100MM TlProduct Code: 1867-15-999 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM TlProduct Code: 1867-15-980 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 9 X70MM TlProduct Code: 1867-15-970 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 8 X80MM TlProduct Code: 1867-15-880 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Synthes – DePuy Spine VIPER POLY SCREW 5.5 8 X70MM TlProduct Code: 1867-15-870 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
DePuy Spine; Inc. Jan-24-2013 DePuy Spine – DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM TlProduct Code: 1867-15-180 Spinal Implant Component. Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium.; VIPER large diameter long screws in high-torque circumstances; the screw shank has the potential to separate from the polyaxial head
Abbott Laboratories Jan-23-2013 ARCHITECT 25-OH Vitamin D Reagent Kit – Abbott Laboratories; ARCHITECT 25-OH Vitamin D Reagent Kit; 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests); 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic. The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
Becton Dickinson & Co. Jan-22-2013 BD MAX ™ (6 channel) Instruments – Becton; Dickinson and Company; BD MAX ™ (6 channel) Instruments; Catalog number 441916; clinical diagnostic instrument. Clinical diagnostic instrument may exhibit minor defects; which could lead to erroneous test results.
AMS Innovative Center – San Jose Jan-22-2013 GreenLight HPS (High Performance System); GreenLight XPS ( Xcelerated Performance System) – GreenLight HPS (High Performance System)GreenLight XPS (Xcelerated Performance System)Manufactured by AMS; Solutions for LifeInnovation Center.GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia. During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Becton Dickinson & Co. Jan-20-2013 BBL Crystal Enteric/Nonfermenter ID Kit – Becton; Dickinson and Company; BBL Crystal Enteric/Nonfermenter ID Kit; Catalog # 24500; cartons of 20 kits; In-vitro diagnostic reagents for microbiological testing.The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli. In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
IDS (Immunodiagnostic Systems Ltd.) Jan-18-2013 IDS – 25-Hydroxy Vitamin D EIA; Catalog #AC-57F1.Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations. Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA; AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report; however the correct value should have read 28.4 ng/mL.
Stryker Howmedica Osteonics Corp. Jan-17-2013 Hoffman LRF Wire Bolt – Hoffman LRF Wire Bolt; Catalog number 4933-1-001 through -003. Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
Spacelabs Healthcare; Llc Jan-17-2013 Spacelabs Smart Disclosure System; Model 92810 – Spacelabs Smart Disclosure System; Model 92810; is an integrated component of the Intesys Clinical Suite (ICS) G2; Version 4.03.The Smart Disclosure product collects patient waveforms; alarms; vital signs; and 12-lead reports. A 24-hour waveform acquisition is standard; with an upgrade option to 72 hours.The product provides basic trends in both tabular and graphical format; along with a retrospective ECG analysis. The analysis may be defined by patient; and the data may be presented in multiple formats; including a rhythm; a histogram; and a summary view.Standard reports are available from Smart Disclosure; including saved events; disclosure; trends; histogram; and summary.The Spacelabs Smart Disclosure System; Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients’ ECG waveform data; that can be annotated and edited; is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network; providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed; with each analysis limited to 24 hours or less. Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2; Version 4.03; Clinical Access portion of Smart Disclosure; Model 92810.
Quanta System; S.p.A. Jan-17-2013 Eterna Giovinezza System – Eterna Giovinezza System; Powered Laser Surgical Instrument.Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne Quanta System S.p.A; Italy; is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Quanta System; S.p.A. Jan-17-2013 Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser – Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument.Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains; hemangiomas; warts; telangiectasia; rosacea; venus lake; leg and spider veins; scars; straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair; for the stable longterm; or permanent; hair reduction; including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI; including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision; excision; ablation; vaporization; coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles; fine lines and wrinkles; treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions. Quanta System S.p.A; Italy; is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Quanta System; S.p.A. Jan-17-2013 Q-Plus T Powered Laser Surgical Instrument – Q-Plus T Powered Laser Surgical InstrumentNd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision; excision; ablation; vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting; vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions. Quanta System S.p.A; Italy; is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Perkinelmer Jan-16-2013 Perkin Elmer NEOBASE NON-DERIVATIZED MSMS KIT – NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U.This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids; succinylacetone; free carnitine; and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders. Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Perkinelmer Jan-16-2013 Perkin Elmer DBS MICROPLATE – DBS MICROPLATE; TRUNCATED V-BOTTOMEDProduct Number: 3033-0010 Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Perkinelmer Jan-16-2013 Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM – NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEMMASS SPECTROMETRY KIT Product Number: 3026-0030.This kit is intended for the measurement and evaluation of amino acid; free carnitine; and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids; free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only; by trained; qualified laboratory personnel. Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Perkinelmer Jan-16-2013 Perkin Elmer Microplate – Microplate; truncated V-bottomed lots included in theabove listed products Product Number: 1380 5465.DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body. Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Perkinelmer Jan-16-2013 Perkin Elmer NEONATAL TOTAL GALACTOSE KIT – NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010; 3029-001B.This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia. Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
DePuy Spine; Inc. Jan-16-2013 DePuy Spine EXPEDIUM Offset Torque Wrench – DePuy Spine EXPEDIUM Offset Torque WrenchProduct Code 2797-29-510The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing; potentially resulting in the instrument recording torque values outside of the specification.
Philips Medical Systems (Cleveland) Inc Jan-16-2013 Computed Tomography X-Ray System Brilliance Workspace Portal – Computed Tomography X-Ray System Brilliance Workspace Portal; Model #728269 Philips Medical Systems; Highland Heights; OH.The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process; analyze; display; quantify and interpret medical images/data. Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4; the coronary arteries in the rendered image are segmented automatically. However; the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
Philips Medical Systems (Cleveland) Inc Jan-15-2013 Brilliance 64 and Ingenuity Computed Tomography (CT) – Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 – Model #728231; and Ingenuity CT – Model # 728326; Distributed By: Philips Healthcare; Cleveland; OH. The Brilliance 64 and Ingenuity CT are Computed Tomography 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 anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
Terumo Cardiovascular Systems Corporation Jan-11-2013 Sarns flexible arterial cannula – Sarns flexible arterial cannula; 6.7 mm (20Fr) OD with 3/8 in. connector; suture ring; 9.5 in (24 cm) longThe Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field; TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Terumo Cardiovascular Systems Corporation Jan-11-2013 Sarns flexible arterial cannula – Sarns flexible arterial cannula; 7.3 mm (22 Fr) OD with 3/8in connector; suture ring; 9.5in (24 cm) longThe Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field; TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Terumo Cardiovascular Systems Corporation Jan-11-2013 Sarns high-flow aortic arch cannula – Sarns high-flow aortic arch cannula; 6.5 mm (20 Fr) OD with 3/8in connector; 11in (28 cm) long; with X coating surfaceThe Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field; TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Terumo Cardiovascular Systems Corporation Jan-11-2013 Sarns high-flow aortic arch cannula – Sarns high-flow aortic arch cannula; 5.2 mm (16 Fr) OD with 3/8in connector; 7.5in (19 cm) longThe Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field; TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Terumo Cardiovascular Systems Corporation Jan-11-2013 Sarns high-flow aortic arch cannula – Sarns high-flow aortic arch cannula; 6.5 mm (20 Fr) OD with 3/8in connector; 11in (28 cm) longThe Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field; TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Terumo Cardiovascular Systems Corporation Jan-11-2013 Sarns flexible arterial cannula – Sarns flexible arterial cannula; 8.0 mm (24 Fr) with 3/8in connector; suture ring; 9.5in (24 cm) longThe Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field; TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Siemens Healthcare Diagnostics; Inc. Jan-10-2013 Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) – Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL).Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma. Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1; E2; and E3 as an application if the AU(R) System is used; the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of
Merit Medical Systems; Inc. Jan-10-2013 Merit Medical’s Custom Procedural Tray – Merit Medical’s Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product’s intended uses. Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation; phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the
Maquet Cardiovascular; LLC Jan-09-2013 CARDIOSAVE Intra-Aortic Balloon Pump – CARDIOSAVE Intra-Aortic Balloon PumpAn electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation. In the Cardiosave Intra-aortic Balloon Pump; there is a possibility that the coiled cord assembly; a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
Zoll Circulation; Inc. Jan-09-2013 AutoPulse Resuscitation System – AutoPulse Resuscitation System Model 100;Mfg by:Zoll CirculationSunnyvale; CA.The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR; on adult patients only; in cases of clinical death as defined by lack of spontaneous breathing and pulse. Complaints associated with an unexpected stop in AutoPulse compressions.
Stryker Communications; Inc. Jan-09-2013 Visum Halogen Surgical Light – (l) Visum Halogen Surgical Light; (2) Visum LED Surgical Light; (3) Stryker Flat Panel & Navigation ArmThe Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light; (2)Visum LED Surgical Light; and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads; is a conduit for power/data; and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly. Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacementof the Spring Arm. If the Spring Arm Circlip is not fully seated; the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date; there have been no serious injuries reported from the incomplete e
Zimmer; Inc. Jan-09-2013 TM Ardis Interbody System Inserter – The TM Ardis Interbody System Inserter Stainless Steel; Rubber; Silicone Non Sterile Rx only.The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically; the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant. Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant
Biomet; Inc. Jan-09-2013 PT-HYBRID – PT113950 PT HYBRID Glenoid PostRegenerex porous titanium constructSterile RProsthesis; Shoulder; Semi-Constrained; Metal/Polymer Cemented Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post; following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events:1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct isimplanted; then a gap of 1-3 mm will be prese
Advanced Sterilization Products Jan-09-2013 STERRAD NX Cassettes – STERRAD NX Cassettes; P/N 10133.The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system. Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product’s labeled shelf-life.
Concentric Medical Inc Jan-08-2013 FlowGate Balloon Guide Catheter; – FlowGate Balloon Guide Catheter;Manufactured by Concentric Medical; Mountain View; CA.FlowGate" Balloon Guide Catheters are coaxial-lumen; braid-reinforced; variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Stryker Howmedica Osteonics Corp. Jan-08-2013 Accolade TMZF Plus Femoral Stem – Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5; Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint. Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Surgical Tissue Network; Inc. Jan-07-2013 Ultrafill DBM – Ultrafill DBM labeled in part: "***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 1cc***Product Code: RT53001***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***"TissueNet’s Porcine DBM product line is used as a bone void filler Surgical Tissue Network Inc.; DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Surgical Tissue Network; Inc. Jan-07-2013 UltraFill DBM – UltraFill DBM labeled in part: "***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***"TissueNet’s Porcine DBM product line is used as a bone void filler. Surgical Tissue Network Inc.; DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Surgical Tissue Network; Inc. Jan-07-2013 UltraFill DBM – UltraFill DBM labeled in part: "***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 10cc***Product Code: RT53010***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***"TissueNet’s Porcine DBM product line is used as a bone void filler. Surgical Tissue Network Inc.; DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Applied Medical Resources Corp Jan-07-2013 Kii Shielded Bladed Access System – Laparoscope; general; plastic surgeryUsed for general; abdominal; gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately.The affected model number is CTB71; and the affected lot is 1179107.
Horiba Instruments; Inc dba Horiba Medical Jan-07-2013 ABX Pentra ML – ABX PENTRA ML; Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
California Medical Laboratories Inc Jan-07-2013 CalMed SU-12202 – Sterile Rigid Tip Suction WandThe Suction Wands are indicated for use to remove excess fluid from the surgical field. California Medical Laboratories; Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application; the distal tip has the potential to come loose from the wand and fall into the patient’s chest cavity.
California Medical Laboratories Inc Jan-07-2013 CalMed SU-12202NS – Rigid Tip Suction WandNon sterile bulk devices (S112468N; S120196N; and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer’s name.The Suction Wands are indicated for use to remove excess fluid from the surgical field. California Medical Laboratories; Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application; the distal tip has the potential to come loose from the wand and fall into the patient’s chest cavity.
Philips Medical Systems North America Co. Phillips Jan-04-2013 Philips HeartStart FRx 861304 Automated External Defibrillator – Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems; Seattle; WA 98121 USA; and Laerdal branded FRx 861305The FRx Defibrillator is intended to treat ventricular fibrillation; the most common cause of sudden cardiac arrest. Using voice prompts; light emitting diodes (LEDs) and buttons; the user is guided through the response. The FRx uses a SMART biphasic; impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children. Philips determined that it is important to clarify information in the Owner’s Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305); OnSite (models M5066A and M5067A); or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o
Siemens Healthcare Diagnostics Inc Jan-04-2013 Siemens Chek-Stix Combo Pak – Siemens Chek-Stix Combo Pak (Distributed OUS only)Catalog Number: 1364NChek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis; CHEK-STIX¿ positive and negative control strips provide defined results for glucose; bilirubin; ketone (acetoacetic acid); specific gravity; blood; pH; protein; urobilinogin; nitrite; and leukocytes When these lots of control material are reconstituted; the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25?C (77?F).
Philips Medical Systems North America Co. Phillips Jan-04-2013 Philips and Laerdal brands of HeartStart HS1 Defibrillator Family – Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A; M5067A; and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems; Seattle; WA 98121 USA.The HS1 Defibrillator is intended to treat ventricular fibrillation; the most common cause of sudden cardiac arrest. Using voice prompts; light emitting diodes (LEDs) and buttons; the user is guided through the response. The HS1 uses a SMART biphasic; impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children. Philips determined that it is important to clarify information in the Owner’s Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305); OnSite (models M5066A and M5067A); or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o
Maquet Inc. Jan-03-2013 Maquet Yuno Extension Table Device – Maquet Yuno Extension Table DeviceMaquet GmbH & Co. KGKehler Strabe 31Baden-Wuerttemberg76437 Rastatt;Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment. There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Cooper Vision Caribbean Corp. Jan-03-2013 AVAIRA Soft Contact Lenses – AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses The lenses exceeded the acceptance limit for silicone oil residual.
Stryker Medical Division of Stryker Corporation Jan-03-2013 Medical Surgical Bed; Model 3002SEX – Medical Surgical Bed; Model 3002SEXMedical Surgical Bed The S3" MedSurg Bed; is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op; post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses; nurses aides; and medical doctors) and human patients. Lockout features may limit patient accessible controls Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15; 2012 and May 23; 2012. The affected beds may have been built with brake rings that do not meet specifications; negatively impacting the holding force of the brakes.
Abbott Molecular Jan-03-2013 Abbott m2000sp Instrument – Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc.; Des Plaines; IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc.; Des Plaines; IL 60018 USA; list 09K14The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. An issue with the m2000sp Instrument software has been identified whereby; after a series of steps; if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen; the changes are not saved.
Horiba Instruments; Inc dba Horiba Medical Jan-03-2013 ABX PENTRA AST CP; – ABX PENTRA AST CP; Part Number: A11A01629.The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit; it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Horiba Instruments; Inc dba Horiba Medical Jan-03-2013 PENTRA C200 – PENTRA C200; Part Number: A11A01629.The Pentra C200 system is a fully automated chemistry analyzer using colorimetry; turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum; plasma and uring. Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit; it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Stryker Medical Division of Stryker Corporation Jan-03-2013 Medical Surgical Bed; Model 3005S3EX – Medical Surgical Bed; Model 3005S3EXMedical Surgical Bed The S3" MedSurg Bed; Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op; post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses; nurses aides; and medical doctors) and human patients. Lockout features may limit patient accessible controls. Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15; 2012 and May 23; 2012. may have been built with brake rings that do not meet specifications; negatively impacting the holding force of the brakes.
Mindray DS USA; Inc. d.b.a. Mindray North America Jan-03-2013 DPM Central Station – DPM Central StationMindray DS USA; Inc. 800 MacArthur Boulevard; Mahwah; NJ 07430The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management; storing; printing; reviewing; or processing of information from net worked devices; and it is operated by medical personnel in hospitals or medical institutions. There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.