April Summary
Class I recalls: 7
Class II recalls: 203
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Draeger Medical Systems; Inc. Apr-10-2014 Draeger Oxylog 3000 plus ventilators – Draeger Oxylog 3000 plus ventilators; emergency and transport ventilator. Part number: 5704833 The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation; gives an audible alarm and displays the error message Poti unplugged.
Del Mar Reynolds Medical; Ltd. Apr-12-2014 Arkon Anesthesia Delivery System – SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Newport Medical Instruments Inc Apr-14-2014 Ventilator – Newport HT70 and HT70 Plus Ventilators; Model Number: HT70 and HT70 Plus.Product Usage:The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically; the HT70 family of ventilators is applicable for infant; pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified; trained personnel under the direction of a physician. The HT70 is suitable for use in hospital; sub-acute; emergency room; and home care environments; as well as for transport and emergency response applications. May emit a continuous high priority alarm and the ventilator may stop ventilating; due to a component failure on the control board.
Micro Therapeutics Inc; Dba Ev3 Neurovascular Apr-16-2014 Alligator Retrieval Device (ARD) – Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal. Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Micro Therapeutics Inc; Dba Ev3 Neurovascular Apr-16-2014 Pipeline Embolization Device (PED) – Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
HeartWare Inc Apr-23-2014 Heartware HVAD Pump Implant Kit – Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100; 1101; 1102; 1103; 1104; and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings; including transportation via fix-wing aircraft or helicopter. The housing to the Pump’s driveline connector became partially or fully separated from the front portion of the driveline connector.
Baxter Healthcare Corp. Apr-25-2014 SIGMA SPECTRUM Volumetric Infusion Pump – SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug LibraryProduct Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs; blood; blood products and mixtures of required patient therapy. Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Allesee Orthodontic Appliances Apr-01-2014 Distalizer Lock Nut Screw – AOA Distalizer Lock Nut Screw; found in products listed as: Distal Jet; Spring Jet; Mesial Jet; and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern. The Lock Nut component of the Jet appliances may be missing the screw collar; which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar; an over-tightened lock nut may stop the piston assembly from moving freely; subsequently preventing intended movement of the teeth.
Infantino LLC Apr-01-2014 – Infantino Squeeze & Teethe Monkey; "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring. Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey; "Go Gaga Squeeze & Teethe Coco the Monkey"; Model Number 206-647; because the tail of the monkey may pose a choking hazard to young children.
Elekta; Inc. Apr-02-2014 Integrity 1.1. – Integrity 1.1.Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
Siemens Medical Solutions Diagnostics Apr-02-2014 Siemens – IMMULITE 2000; IMMULITE 2000XPi; VersaCellThe IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum; plasma; or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems; such as the IMMULITE 2000 There is a potential for incorrect results to be reported from processing of a sample tube.
3M Company – Health Care Business Apr-02-2014 3M" Steri-Vac" Gas Sterilizer/Aerators – 3M" Steri-Vac" Gas Sterilizer/Aerators; Model #’s 4XL;5XL; 8XLThe 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY. Recently; 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10; 2006 through December 14; 2007 and in service during the period February 7; 20
Roche Diagnostics Operations; Inc. Apr-02-2014 Omni Micro-electrode for cobas b221 analyzer – Omni Micro-electrode/reference electrode for cobas b221 analyzer; Model/Catalog/Part Number:03111873180 as a part of the following systems:1. 03337103001; cobas b 221<1>Roche OMNI S1 system2. 03337111001; cobas b 221<2>Roche OMNI S2 system3. 03337154001;cobas b 221<6>Roche OMNI S6 system4. 03337138001; cobas b 221<4>Roche OMNI S4 systemProduct Usage: Usage:Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH; Blood gases; electrolytes; Hematocrit; hemoglobin; glucose; lactate; urea/BUN; total hemoglobin; Oxygen saturation; oxy – deoxycarboxy and methemoglobin Reference electrode used beyond the guaranteed in-use 52 week lifetime;may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.
Stryker Howmedica Osteonics Corp. Apr-02-2014 Howmedica Osteonics Corp. – Citation TMZF HA 132 degrees Neck Angle; V40 Hip Stem – Right Size #3: catalog # 6265-5113 ; Left Size #4: catalog #6265-5104 ; and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants. Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem – Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem – Right Size #3.
Teleflex Medical Apr-02-2014 Weck Vista Universal Laparoscopic Port – Weck Vista Universal Laparoscopic Port; Size 5/10mm x 100mm; Catalog No. 405910; Weck Vista Universal Laparoscopic Port; Size 5/10/12mm x 100mm; Catalog No. 405912; Weck Vista Universal Laparoscopic Port; Size 5/10/12mm x 125mm; Catalog No. 40591213.An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals. Complaints of leakage of insufflation gas through the device.
Teleflex Medical Apr-02-2014 5/10 Weck Vista Universal Balloon Open Access Port – 5/10 Weck Vista Universal Balloon Open Access Port – Standard Length (70mm); Catalog No. 410944; 5/10 Weck Vista Universal Balloon Open Access Port – Long Length (100mm); Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port – Short Length (53mm); Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port – Standard Length (70mm); Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port – Long Length (100 mm); Catalog No. 412944L.An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals. Complaints of leakage of insufflation gas through the device.
Teleflex Medical Apr-02-2014 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access – 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access; Catalog No. 405933.An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals. Complaints of leakage of insufflation gas through the device.
Teleflex Medical Apr-02-2014 10mm Weck Vista Cannula – 10mm Weck Vista Cannula-only; Catalog No. 405910C; 12mm Weck Vista Cannula-only; Catalog No. 405912C.An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals. Complaints of leakage of insufflation gas through the device.
Teleflex Medical Apr-02-2014 5/10 mm Weck Vista Universal Cannula – 5/10 mm Weck Vista Universal Cannula; Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula; Catalog No. 405912RC.An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals. Complaints of leakage of insufflation gas through the device.
Teleflex Medical Apr-02-2014 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port – 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port; Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port; Catalog No. 405912R.An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals. Complaints of leakage of insufflation gas through the device.
Ormco/Sybronendo Apr-02-2014 Titanium Orthos Brackets – Titanium Orthos Brackets; an orthodontic bracket. 022 +9/+9/0; Part Number 449-6212; Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment. Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0); Part Number 449-6212; Lot Number 121359169; because the color ID dot was marked on the wrong tie-wing of the brackets.
Ethicon; Inc. Apr-03-2014 Ethicon Inc. – Proceed Surgical Mesh; Product Codes PCDB1; PCDT1; and PCDJ1. Ethicon Inc.; Johnson & Johnson Medical GmbH; used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Merit Medical Systems; Inc. Apr-03-2014 Merit Custom Syringe Kit – Merit Custom Syringe Kit; Convenience Kit; I.R. Embolization Pack; K02-01010A; Sterile EO. The products are labeled as sterile but were not sterilized.
Merit Medical Systems; Inc. Apr-03-2014 Pressure Monitoring Tubing – Pressure Monitoring Tubing; PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer. The products are labeled as sterile but were not sterilized.
Siemens Medical Solutions USA; Inc. Apr-03-2014 ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe – Siemens Medical Solutions; ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit.
Energizer Personal Care Apr-04-2014 Playtex Nurser Deluxe Double Electric Breast Pump – Playtex Nurser Deluxe Double Electric Breast Pump; Model X06578AO; powered by a 12V DC power supply; Model SY-12120; which is included with the package. Some of the power adapters outer casings may become loose and separate; resulting in a potential for electric shock.
Ormco/Sybronendo Apr-04-2014 Spirit MB Bracket – Spirit MB Bracket; UR Central +14T +5A.018; Part Number 494-0110; Lot Number 081351013.Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment. Ormco Corporation initiated this recall of Spirit MB Brackets; Part Number 494-0110; Lot Number 081351013; because the ID dot; which designates the bracket as distal/gingival; is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth; leading to movement 10 degrees in the wrong direction.
Intuitive Surgical; Inc. Apr-04-2014 5X300 MM Curved Cannula; Arm 1 – 5X300 MM Curved Cannula; Arm 1for use with daVinci SI Surgical System; model number IS3000.Intuitive Surgical1266 Kifer RoadSunnyvale; CA 94086The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue; grasping; cutting; blunt and sharp dissection; approximation;clip- ligation; electrocautery and suturing during single incision laparoscopic cholecystectomy; benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories; including graspers; dissectors; needle drivers; scissors; suction irrigators;monopolar cautery; bipolar cautery; 5mm curved cannulae;5mm and 10 mm straight cannulae; flexible blunt obturators; and the 5mm Single-Site Port. Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Intuitive Surgical; Inc. Apr-04-2014 5X250 MM Curved Cannula; Arm 1 – 5X250 MM Curved Cannula; Arm 1for use with daVinci SI Surgical System; model number IS3000.Intuitive Surgical1266 Kifer RoadSunnyvale; CA 94086The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue; grasping; cutting; blunt and sharp dissection; approximation;clip- ligation; electrocautery and suturing during single incision laparoscopic cholecystectomy; benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories; including graspers; dissectors; needle drivers; scissors; suction irrigators;monopolar cautery; bipolar cautery; 5mm curved cannulae;5mm and 10 mm straight cannulae; flexible blunt obturators; and the 5mm Single-Site Port. Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Intuitive Surgical; Inc. Apr-04-2014 5X300 MM Curved Cannula; Arm 2 – 5X300 MM Curved Cannula; Arm 2for use with daVinci SI Surgical System; model number IS3000.Intuitive Surgical1266 Kifer RoadSunnyvale; CA 94086The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue; grasping; cutting; blunt and sharp dissection; approximation;clip- ligation; electrocautery and suturing during single incision laparoscopic cholecystectomy; benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories; including graspers; dissectors; needle drivers; scissors; suction irrigators;monopolar cautery; bipolar cautery; 5mm curved cannulae;5mm and 10 mm straight cannulae; flexible blunt obturators; and the 5mm Single-Site Port. Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Intuitive Surgical; Inc. Apr-04-2014 5X250 MM Curved Cannula; Arm 2 – 5X250 MM Curved Cannula; Arm 2for use with daVinci SI Surgical System; model number IS3000.Intuitive Surgical1266 Kifer RoadSunnyvale; CA 94086The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue; grasping; cutting; blunt and sharp dissection; approximation;clip- ligation; electrocautery and suturing during single incision laparoscopic cholecystectomy; benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories; including graspers; dissectors; needle drivers; scissors; suction irrigators;monopolar cautery; bipolar cautery; 5mm curved cannulae;5mm and 10 mm straight cannulae; flexible blunt obturators; and the 5mm Single-Site Port. Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Aspen Surgical Products; Inc. Apr-07-2014 Saber 100ml Infection Control PVC Bulb with 150ml 3C System; Sterile (10/case) – Saber 100ml Infection Control PVC Bulb with 150ml 3C System; Sterile (10/case)Intended to provide manual suction and collection of fluids for closed wound drainage systems The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 15FR Drain Kit; Flat Full Perforated with Trocar; Saber 100ml Bulb and 3C System; Sterile (10/case) – 15FR Drain Kit; Flat Full Perforated with Trocar; Saber 100ml Bulb and 3C System; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 Saber 100ml Infection Control PVC Bulb Evacuator; Sterile (10/case) – Saber 100ml Infection Control PVC Bulb Evacuator; Sterile (10/case)Intended to provide manual suction and collection of fluids for closed wound drainage systems The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 19FR Drain Kit Flat Full Perforated with Trocar; Saber 100ml Bulb and 3CSystem; Sterile (10/case) – 19FR Drain Kit Flat Full Perforated with Trocar; Saber 100ml Bulb and 3CSystem; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb; Sterile (10/case) – 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10FR Drain Kit; Flat Full Perforated with Trocar; Saber 100ml Bulb and 3C System; Sterile (10/case) – 10FR Drain Kit; Flat Full Perforated with Trocar; Saber 100ml Bulb and 3C System; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb; Sterile (10/case) – 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb; Sterile (10/case) – 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 7mm Drain Kit; Flat Full Perforated; Saber 100ml Bulb and 3C System Sterile (10/case) – 7mm Drain Kit; Flat Full Perforated; Saber 100ml Bulb and 3C System Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10mm Drain Kit; Flat Full Perforated; Saber 100ml Bulb and 3C System Sterile (10/case) – 10mm Drain Kit; Flat Full Perforated; Saber 100ml Bulb and 3C System Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb; Sterile (10/case) – 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb; Sterile (10/case)Intended for closed wound suction drainage The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Aspen Surgical Products; Inc. Apr-07-2014 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case) – 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator; Sterile (10/case)10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac BulbSterile (10/case)10mm Drain Kit; Flat Full Perforated with Trocar; Saber 100mlBulb and 3C System Sterile (10/case) The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
LumiQuick Diagnostics Inc. Apr-07-2014 Tramadol Test Card – Tramadol Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Benzodiazepine Strip – Benzodiazepine Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 THC Test Card – THC Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Ketamine Test Card – Ketamine Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 K2 (synthetic Marijuana) Test card – K2 (synthetic Marijuana) Test card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Dengue IgG/IgM – Dengue IgG/IgM;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Adenovirus Antigen Test Card – Adenovirus Antigen Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 PCP Test (Strip) – PCP Test (Strip);LumiQuick; Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 PSA Test Card (Whole Blood) – PSA Test Card (Whole Blood);LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Dengue NS1 Antigen Test Card – Dengue NS1 Antigen Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Fecal Occult Blood Test Card – Fecal Occult Blood Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Cocaine Strip – Cocaine Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Oxycodone Strip – Oxycodone Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Methylphenidate Test Strip – Methylphenidate Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Dengue NS1 Ag/IgG/M Ab Duo Test Card – Dengue NS1 Ag/IgG/M Ab Duo Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Rotavirus Test Card – Rotavirus Test CardLumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Amphetamine Test Card – Amphetamine Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Malaria pf Antigen Test Card – Malaria pf Antigen Test Card;Flumiquil;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 PSA Test Card (Serum) – PSA Test Card (Serum);LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 H. Pylori Antibody Test Card (Whole Blood) – H. Pylori Antibody Test Card (Whole Blood)LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Fentanyl Test Card – Fentanyl Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Oxycodone Test Card – Oxycodone Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Malaria pan Antigen Test – Malaria pan Antigen Test;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Tuberculosis Antibody Test Card Serum – Tuberculosis Antibody Test Card Serum;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 CK-MB Test Card (Whole Blood) – CK-MB Test Card (Whole Blood);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 MDMA/Ecstasy Test Card – MDMA/Ecstasy Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Methadone Test Card – Methadone Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 THC Strip – THC Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Fentanyl Test Strip – Fentanyl Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Morphine Strips (2000); – Morphine Strips (2000);LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 EDDP Strip – EDDP Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Myoglobin Test Card (Whole Blood) – Myoglobin Test Card (Whole Blood);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Myoglobin Test Card (Serum) – Myoglobin Test Card (Serum);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 PCP Test Card – PCP Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 CK-MB Test Card (serum) – CK-MB Test Card (serum);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 H. Pylori Antigen Test Card – H. Pylori Antigen Test CardLumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Malaria pf Antigen Test Card – Malaria pf Antigen Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Tramadol Strip – Tramadol Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Clonazepam Test Card – Clonazepam Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Propoxyphene Test Strip – Propoxyphene Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Amphetamine Strip – Amphetamine Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 K2 (synthetic Marijuana) Test Strip – K2 (synthetic Marijuana) Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 EDDP Test Card – EDDP Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Troponin I test Card (Whole Blood) – Troponin I test Card (Whole Blood);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Salmonella typhi/paratyphi Antigen Test – Salmonella typhi/paratyphi Antigen Test;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 H. Pylori Ab Test Card-Serum – H. Pylori Ab Test Card-Serum;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Buprenorphine Test Strip – Buprenorphine Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Legionella Test Card – Legionella Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Methamphetamine Test Card – Methamphetamine Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Morphine Test Card (300 – Morphine Test Card (300);LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Alcohol Test; Urine – Alcohol Test; Urine;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Methylphenidate Test Card – Methylphenidate Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Cardiac Panel Test Card (Whole Blood) – Cardiac Panel Test Card (Whole Blood);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Syphilis Test Strip (Serum – Syphilis Test Strip (Serum)LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Alcohol Test; Saliva – Alcohol Test; Saliva;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Drugs of Abuse Panel Test Device – Drugs of Abuse Panel Test Device;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 MDMA/Ecstasy Strip – MDMA/Ecstasy Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Syphilis Test Card (Serum) – Syphilis Test Card (Serum);LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Malaria pf/pan Antigen Test Card – Malaria pf/pan Antigen Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Benzodiazepine Test Card – Benzodiazepine Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Morphine Strip (300 – Morphine Strip (300);LumiQuick; Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Propoxyphene Test Strip – Propoxyphene Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Barbiturate Test Card – Barbiturate Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Barbiturate Strip – Barbiturate Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Fecal Occult Blood Test Strip – Fecal Occult Blood Test Strip;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Adeno/Rota Combo Test Card – Adeno/Rota Combo Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Strep A Test Card – Strep A Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Methadone Test Strip – Methadone Test Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Troponin I test Card (serum); – Troponin I test Card (serum);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Cardiac Panel Test (Serum) – Cardiac Panel Test (Serum);LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Cocaine Test Card – Cocaine Test Card;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Methamphetamine Strip – Methamphetamine Strip;LumiQuick; Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Ketamine Strip – Ketamine Strip;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Syphilis Test Card Whole Blood(Serum) – Syphilis Test Card Whole Blood(Serum)LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Rickettsia IgG/IgM Test Card – Rickettsia IgG/IgM Test CardLumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Salmonella typhi Antigen Test Card – Salmonella typhi Antigen Test Card;LumiQuick;Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Fentanyl Test Card – Fentanyl Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Buprenorphine Test Card – Buprenorphine Test Card;LumiQuick;.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Morphine Test Card (2000) – Morphine Test Card (2000);LumiQuick; Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
LumiQuick Diagnostics Inc. Apr-07-2014 Salmonella typhi IgG/IgM Duo Test – Salmonella typhi IgG/IgM Duo Test;LumiQuick.Santa Clara; CA 95054 Products shipped to US locations that do not have approved applications for PMA ; IDE or 510(k) clearance.
Remington Medical Inc. Apr-09-2014 FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. – FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.Electrical extension cable intended to transmit signal from; or power or excitation signal to patient connected electrodes. The cable is a sterile; disposable device. Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically; the polarity for the black chuck in the picture is wrong. It shows (+); but should show (-).
Alcon LenSx; Inc. Apr-09-2014 Common Name: LenSx Laser System. – Alcon LenSx Ophthalmic Laser; for use in cataract surgery for the creation of corneal cuts/incisions; anterior capsulotomy and laser phacofragmentation. Alcon LenSx received reports of unexpected downward motion of the gantry.
Smiths Medical ASD; Inc. Apr-09-2014 Smiths Medical – Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravityconditions Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Smiths Medical ASD; Inc. Apr-09-2014 Smiths Medical – Smiths Medical HOTLINE Fluid Warming Set L-70.Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
Philips Medical Systems; Inc. Apr-09-2014 Philips Healthcare – Philips HeartStart XL+ Defibrillator/Monitor with systemsoftware version B.00.00 or B.00.01 installedModel: 861290; automatic external defibrillator. Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
Clinical Diagnostic Solutions Apr-09-2014 Boule Con-Diff Tri-Level – Boule Con-Diff Tri-LevelMulti-Parameter Assayed Hematology Control; used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Elevated MCV results on the 1311-682; 1311-683; and 1311-684 lots.
DePuy Orthopaedics; Inc. Apr-09-2014 GLOBAL APG+ 2.5mm Guide Pin – GLOBAL Anchor Peg Glenoid Plus(APG+) 2.5MM Breakaway Guide PinPart # 2230-00-019; Non-Sterile; DePuy; Johnson & JohnsonProduct Usage: Usage:The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+; GLOBAL STEPTECH APG; and DELTA XTEND Systems. The guide pin is scored in three locations; which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel. Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.
Philips Medical Systems; Inc. Apr-09-2014 Philips Healthcare – Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290; automatic external defibrillator. A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
Draeger Medical; Inc. Apr-10-2014 Drger Breathing Bag – Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets.Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out. Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR.A
ErgoSafe Product LLC dba Prism Medical Services Apr-10-2014 Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly – 400003 Medcare Lift with Scale400013 Medcare Lift w/Scale 600 lb400600 Scale Hanger AssemblyProduct Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift; transfer or position clients. MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare’s high standards. The original design includes a pin that over time and years of use may stop performing as designed and may break.
Breg Inc Apr-10-2014 Economy Elastic Knee Sleeve Open; Model No. 121414 and 121415. – Economy Elastic Knee Sleeve Open; Model No. 121414 and 121415.Product Usage: The product is intended to provide flexible knee support. Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Breg Inc Apr-10-2014 K-Lite Knee 2 Stays with Visco; Model No. 122015. – K-Lite Knee 2 Stays with Visco; Model No. 122015.Product Usage:The product is intended to provide flexible knee support. Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Central Purchasing LLC DBA Harbor Freight Tools Apr-10-2014 Sit/stand Rolling Walker – Sit/stand Rolling Walker; SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less. Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838; sold June 2009 to March 2014) because; over time; there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame; presenting a potential hazard for the user.
Roche Diagnostics Operations; Inc. Apr-10-2014 Cobas c8000 Modular Analyzer Series – Cobasc502 – Cobas c8000 Modular Analyzer Series Cobas c502; Part Number 5964067001; a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
Pega Medical Inc. Apr-10-2014 Fassier-Duval IM Telescopic System – Pega Medical Inc.; Fassier-Duval IM Telescopic System; male component (solid shaft); Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Gambro Renal Products; Incorporated Apr-11-2014 Gambro Cartridge Blood Set – Gambro Cartridge Blood Set; blood transport system for hemodialysis; Model Number(s): 101025 (003410510) – Cartridge set; STND PRM LN and 103401 (003414500) – Cartridge set; PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems. Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Synthes; Inc. Apr-14-2014 Synthes – Synthes CMF Battery Powered Driver; Part no. 305.840. Used to place screws in the cranialfacial bones; and to drill and/or tap holes to prepare cranialfacial bones for screw insertion. The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver; taps; screwdriver blades; and a screw holding sleeve. However; the device is not intended to be used in conjunction with a tap for tapping holes in a patient’s skull; upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
Biomet 3i; LLC Apr-15-2014 BIOMET 3i Endosseous Dental Implant – BIOMET 3i Endosseous Dental Implant. Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Synthes; Inc. Apr-15-2014 The Synthes Hohmann Retractor – The Synthes Hohmann Retractor; 43 mm Long Shank; Angled 235 mm Product Usage: Used to expose bone for procedures. The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
Edwards Lifesciences; LLC Apr-16-2014 Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae – Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae; arterial cannula sizes 16; 18 and 20 French; models: FEMII016A; FEMII016AS; FEMII018A; FEMII018AS; FEMII020A; and FEMII020AS. Potential for separation of dilator tips.
Edwards Lifesciences; LLC Apr-16-2014 Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo coating – Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating; arterial cannula sizes 16; 18 and 20 French; Models DFEMII016AS; DFEMII018AS; DFEMII020AS; DIIFEMII016A; DIIFEMII018A; and DIIFEMII020A. Potential for separation of dilator tips.
Philips Medical Systems (Cleveland) Inc Apr-16-2014 Brilliance CT 16; Brilliance CT 64; Brilliance CT Big Bore Oncology; Brilliance CT Big Bore Radiolog – Brilliance CT 16; Brilliance CT 64; Brilliance CT Big Bore Oncology; Brilliance CT Big Bore Radiology; Brilliance iCT; Ingenuity CT; Ingenuity Core; Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems. Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier; causing premature fracture of the threaded rod on the patient support service latch. As a result; the table top can become free floating due to the disengaged service latch in the table tops subframe.
GE OEC Medical Systems; Inc Apr-16-2014 OEC 9900 Elite – The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography; endoscopy; urologic; orthopedic; neurologic; vascular; cardiac; critical care and emergency room procedure. The system may be used for other imaging applications at the physician’s discretion. GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems; causing the spring arm and monitor to fall forward.
Solta Medical; Inc. Apr-16-2014 Fraxel Laser System – FRAXEL DUAL 1550/1927 Laser System; (FRAXEL SR 1500 DUAL Laser System); for dermatological procedures. Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.
Terumo Cardiovascular Systems Corp Apr-16-2014 Terumo Cardiovascular Systems Kit- X-Coated Pump and Table Pack – Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RECatalog Number: 73431 Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
Siemens Medical Solutions USA; Inc Apr-16-2014 Siemens – AXIOM Vertix MD Trauma systemsradiographic X-ray There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases; steel ropes inside the lift column of the system can be defective without triggering the safety lock; which can result in the U-arm dropping down unexpectedly during movement in vertical direction; potentially causing serious injury.
CareFusion 303; Inc. Apr-16-2014 SmartSite Extension Set – SmartSite Extension Set; Model No. 20029E; intravascular administration set. Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
Philips Medical Systems (Cleveland) Inc Apr-16-2014 Ingenuity Core128 – Ingenuity Core 128; Computed Tomography X-ray systems; Philips Medical Systems (Cleveland); Inc. A customer reported that after upgrading to software version 3.5.5 from 3.5.4; reconstructions would intermittently not complete.
Ortho-Clinical Diagnostics Apr-17-2014 VITROS Chemistry Products CRBM Slides – VITROS Chemistry Products CRBM Slides; REF 889 2382; IVD — Ortho-Clinical Diagnostics; Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides; Lot 3920-0080-8403.
Codman & Shurtleff; Inc. Apr-17-2014 "CODMAN CERTAS Programmable Valves – CODMAN CERTAS Programmable Valves; central nervous system shunt; models as follows: 82-8800 In Line Valve Only82-8801 In Line Valve with Catheter and Accessories82-8802 In Line Valve with Unitized Catheter and Accessories82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories82-8804 In Line Valve only with SIPHONGUARD Device82-8805 In Line Valve with SIPHONGUARD Device; Catheter and Accessories82-8806 In Line Valve with SIPHONGUARD; Unitized Catheter and Accessories82-8807 In Line Valve with SIPHONGUARD Device; Unitized BACTISEAL Catheter and Accessories82-8850 Certas Therapeutic Management System" Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
Brainlab AG Apr-17-2014 Spine & Trauma 3D 2.0 – Brainlab; Spine & Trauma 3D 2.0; Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g.; CT data sets to the current patient anatomy visible on fluoroscopic images; used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated
Pega Medical Inc. Apr-18-2014 Fassier-Duval IM Telescopic System – Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS.-Duval IM Telescopic System. The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
BioMerieux SA Apr-18-2014 ZYM B Reagent (REF 70493) – ZYM B Reagent (REF 70493).The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests; which enables group or species identifications of microorganisms. bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
BioMerieux SA Apr-18-2014 API Listeria (REF 10300) – API Listeria (REF 10300).ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
BioMerieux SA Apr-18-2014 FB Reagent (REF 70562) – FB Reagent (REF 70562).FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests; which enables group or species identifications of microorganisms. bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
Remel Inc Apr-18-2014 Oxoid Legionella Pneumo Groups 2-14 – Oxoid Legionella Pneumo Groups 2-14; DR0802M; containing 50 tests per box. The box contains a variety of components; one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent; DR0802. The responsible firm on the label is Oxoid Ltd.; Basingstoke; Hants; England. A reagent contained within the product may return false negative results.
BioMerieux SA Apr-18-2014 API NIH (REF 10400) – API NIH (REF 10400).ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API’s are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
Remel Inc Apr-18-2014 Oxoid Legionella Latex Test – Oxoid Legionella Latex Test; DR0800M; containing 50 tests per box. The box contains a variety of components; one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent; DR0802. The responsible firm on the label is Oxoid Ltd.; Basingstoke; Hants; England. A reagent contained within the product may return false negative results.
Hospira Inc. Apr-21-2014 LifeShield HemoSet I.V. PlumSet – LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet; Nonvented; 105 inch with Prepierced Reseals; OPTION-LOK and Inline Dual Channel Cassette.For administration of blood and blood bags for use with Plum Series Infusers. Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03; a HemoSet containing a burette and blood filter; intended for infusion of blood/blood products. In a gravity delivery; the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
GE Healthcare; LLC Apr-21-2014 GE Healthcare; Discovery MR450; Discovery MR750; Optima MR450w; Optima MR 450w GEM; Discovery MR750w – GE Healthcare; Discovery MR450; Discovery MR750; Optima MR450w; Optima MR 450w GEM; Discovery MR750w; and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. Potential safety issue with gradient coil electromechanical connections associated with GE MR Products.Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which; in turn; can cause material in the Rear Endbell enclosure to overheat; generate smoke in the scan room; and cause some localize
RAYSEARCH LABORATORIES AB Apr-21-2014 Ray Station 2.0; 2.5; 3.0; 3.5 and 4.0 – RaySearch Ray Station Radiation Therapy Treatment Planning System; Stand-alone software. Versions 2.0; 2.5; 3.0; 3.5 and 4.0. RaySearch Laboratories has recalled "RaySearch Ray Station 2.0; 2.5; 3.0; 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
Boston Scientific Corporation Apr-22-2014 iLab Ultrasound Imaging System – iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec; the Longview distance measurement may display an inaccurate value that is double the actual distance.
Merit Medical Systems; Inc. Apr-22-2014 Merit Laureate Hydrophilic Guide Wire – Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire; Angled Tip; Standard Shaft; Catalog No. LWSTDA35260EX; 260 cm (102"). Merit Medical Systems; Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire; catalog number LWSTFS35260EX; lot number K556399 (173 units); which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate0.035" 260 cm Guide Wire; catalog number LWSTDA3
Merit Medical Systems; Inc. Apr-22-2014 Merit Laureate Hydrophilic Guide Wire – Merit Laureate Hydrophilic Guide Wire; Catalog No. LWSTFS35260EX; Straight Tip Stiff Shaft; 0.035" (0.89mm); 260 cm (102"). Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire; catalog number LWSTFS35260EX; which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate0.035" 260 cm Guide Wire; catalog number LWSTDA35260EX; which has an angled tip; standard shaft and Chinese unit labeling.
Ortho-Clinical Diagnostics Apr-23-2014 VITROS Chemistry Products CDM PROM – VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168; Catalog Number/REF 199 9077; used in conjunction with: VITROS Chemistry Products CRSC DT Slides; Generation (GEN) 82; REF 6802721; andVITROS DT Calibrator Kit; Product Code 1957924; and tested on the VITROS DT60/DT60 II Chemistry System; IVD — Ortho-Clinical Diagnostics; Inc. Customers were unable to calibrate; or use previously calibrated; VITROS DT CRSC slides (REF/Product Code 6802721); GEN 82; on the VITROS DT II System; when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077); as CDM 168 does not contain calibration parameters for DT CRSC.
Ev3; Inc. Apr-23-2014 EverCross 0.035" OTW PTA Dilatation Catheter – ev3 EverCross 0.035" OTW PTA Dilatation Catheter; 6mm x 120mm x 135cm; REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter; 6mm x 40mm x; 80cm REF: AB35W06040080. Peripheral Dilatation Catheter Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
GE Healthcare; LLC Apr-23-2014 GE Ultrasound Vivid E9 – GE Vivid E9 Ultrasound System; a general-purpose ultrasound system; specialized for use in cardiac imaging. GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D; C2-9-D; IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
Siemens Medical Solutions USA; Inc. Apr-24-2014 ACUSON X700 Ultrasound Systems – Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00; 1.0.01; 1.0.02; 1.1.00 and 1.1.02. ultrasound imaging system. When fourSight 4D ultrasound imaging; 3-Scrape real time 3D imaging; or Anatomical M-mode are used during an Obstetric or Gynecology study; data from the previous patient could replace the current patient’s date in the report.
Philips Medical Systems; Inc. Apr-24-2014 Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software – Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software; softwareapplication that is used for receiving; managing; archiving; distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving; managing; archiving; distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT; MR; US; NM; XA; RF; computed and direct radiographic devices; secondary capture devices; scanners; imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals; including but not limited to radiologists; clinicians. technologist and others Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x; may have incorrect density measurement on Enhanced CT/MR examinations
Branan Medical Corporation Apr-24-2014 ToxCup Drug Screen Cup – ToxCup Drug Screen Cup; Catalogue Numbers: HT15; HT15A; PT11; PT11A; PT15A; PT23A; a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Teleflex Medical Apr-24-2014 Sengstaken Tube and Sengstaken-Blakemore Tube – Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800; 204802; and 204803; a gastrointestinal tube and accessories; consisting of flexible or semi-rigid tubing used for instilling fluids into; withdrawing fluids from; splinting; or suppressing bleeding of the alimentary tract. Sterility of the product cannot be guaranteed.
Varian Medical Systems; Inc. Apr-24-2014 On-Board Imager model H08 – On-Board Imager – Exact Arm Elbow Motor Shaft (kVD; kVS; and MV) with ”Type 01" elbow motors.Product Usage:The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks. Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
Arrow International Inc Apr-24-2014 Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter – Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter; catalogue number AK-45854-CDC. Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion ofthe lidstock states that the kit contains 8.5FR x 16CM catheter; while the rest of the lidstockcorrectly identifies the catheter as 8.5FR x 20CM
Ion Beam Applications S.A. Apr-24-2014 Proteus 325 – Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher; models 110; 112; 113; and 116.Proton therapy Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
Philips Medical Systems; Inc. Apr-24-2014 Digital Diagnost; stationary radiographic system – Digital Diagnost; stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position; the footboard is not securely held.
Altasource LLC dba Meta Labs LLC Apr-24-2014 Amo-O Herbal Stimulator – Amo-O Herbal Stimulator; 2 fl. oz. Manufactured by Meta Labs; Alpharetta; GA 30076; UPC Code 80702-1Product Usage:The product is a nonprescription; topical gel that is used to enhance libido and stimulate orgasmic pleasure. Firm is not registered as a drug manufacturer.
Altasource LLC dba Meta Labs LLC Apr-24-2014 Hot Ice – Hot Ice; 1 fl. oz.; Meta Labs LLC; UPC 80705-2Product Usage:A topical gel that increases men and womens secual excitement and pleasure. Firm is not registered as a drug manufacturer.
Altasource LLC dba Meta Labs LLC Apr-24-2014 Nice-En-Smooth Berry Burst – Nice-En-Smooth Berry Burst; 4 oz.; Manufactured by Meta Labs LLC; UPC 80604-8Product Usage:Flavored lubricant water based; condom friendly jelly used to enhance or replace a womans natural lubrication. Firm is not registered as a drug manufacturer.
Zimmer; Inc. Apr-24-2014 TRABECULAR METAL MODULAR ACETABULAR SYSTEM – TRABECULAR METAL MODULAR ACETABULAR SYSTEM; Shell with Cluster Holes; Porous 60mm. Catalog number 00-6202-060-22; Hip implant component. The shell was missing the locking ring.
Altasource LLC dba Meta Labs LLC Apr-24-2014 Mega-Gen His Personal Lubricant – Mega-Gen His Personal Lubricant; 8 fl. oz.; Meta Labs; UPC Code 80708-3; Mega-Gen Hers Personal Lubricant; 8 fl. oz.; Meta Labs; UPC Code 80808-0Product Usage:A topical gel that increases sexual excitement and pleasure. Firm is not registered as a drug manufacturer.
Teleflex Medical Apr-24-2014 Monofilament and Multifilament Nonabsorbable Steel Suture – Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2; 29-727; 29-7270M4; 29-7281M4; E29-5553M4; E29-7270M4; E29-7272M4; E29-727A; EP4013P; EP4110N; X-2235; X29-7271M2; X-5667M8 and X-6730M5. The products are being recalled because they did not meet minimum diameter requirements.
Arrow International Inc Apr-24-2014 Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet – Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS; peripherally inserted central catheter. Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.
Stryker Instruments Div. of Stryker Corporation Apr-24-2014 PenAdapt"(PenAdapt is a TM of Buffalo Filter) – Stryker PenAdapt"; Rx Only; Sterile.This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke; particles; and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing. During packaging verification testing; a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the
Siemens Medical Solutions USA; Inc Apr-24-2014 Siemens MULTIX FUSION – MULTIX FUSION.The Multix Fusion system is a radiographic system used in hospitals; clinics; and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull; chest; abdomen; and extremities and may be used on pediatric; adult and bariatric patients. It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose; and could potentially crash down during an examination.
Siemens Healthcare Diagnostics Apr-25-2014 IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE – IMMULITE2000 /IMMULITE 2000 XPi Systems TIE Total IgE; REF L2KIE2; SMN 10380873; and L2KIE6; SMN 10380872; IVD — Siemens Healthcare Diagnostics Products Ltd. Llanberis; Gwynedd; LL55 4EL; UK.For in vitro diagnostic use with the IMMULITE; IMMULITE 1000; and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers – for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum. Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Siemens Healthcare Diagnostics Apr-25-2014 IMMULITE /IMMULITE 1000 Systems TIE Total IgE – IMMULITE /IMMULITE 1000 Systems TIE Total IgE; REF LKIE1; SMN 10380867; IVD — Siemens Healthcare Diagnostics Products Ltd. Llanberis; Gwynedd; LL55 4EL; UK.For in vitro diagnostic use with the IMMULITE; IMMULITE 1000; and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers – for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum. Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Acumed LLC Apr-25-2014 Osteo-Clage Stainless Steel Bone Plate – The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S2.0 mm SS Sleeve Only; Part Number 01-0022-S8; 7 hole; SS compression plate; Part Number 02-2007-S10; 9 hole; SS compression plate; Part Number 02-2009-SProduct Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight; rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage dixation procedures Acumed is voluntarily recalling specific lot numbers of Osteo-Clage Stainless Steel Bone Plates and Tension Band Pins due to the manufacturing of these devices with a grade of stainless steel that is not within specifications.
Brainlab AG Apr-25-2014 ExacTrac 6.0 – ExacTrac 6.0 is a patient positioning and monitoring system.Model/catalogue numbers:20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.349926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED49973B ET DATA PREP / REVIEW SYSTEM49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED When using multiple radiation treatment targets within a single plan; the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result; there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
Acumed LLC Apr-25-2014 Acumed Tension Band Pin – The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire.50.0 mm Tension Band Pin; Part Number 30-009770.0 mm Tension Band Pin; Part Number 30-009890.0 mm Tension Band Pin; Part Number 30-009950.0 mm Tension Band Kit; Part Number TB-1550K-S70.0 mm Tension Band Kit; Part Number TB-1570K-S90.0 mm Tension Band Kit; Part Number TB-1590K-SProduct Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar; patella; and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine. Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
Elekta; Inc. Apr-25-2014 HexaPOD evo RT Couchtop – HexaPOD evo RT Couchtop.To support and aid in positioning a patient during radiation therapy. If screws are not properly tightened with a torque wrench they may become loose over time.
Teleflex Medical Apr-25-2014 Monodek – Monodek Violet Synthetic Absorbable Surgical Sutures; MF 0 TC43/HR26 48 Product does not meet minimum knot tensile strength requirements.
GE Healthcare; LLC Apr-25-2014 GE Healthcare; CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) – GE Healthcare; CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #’s 5434389-2 and 5434384-2.The GE Cardiac VX for MRI is an analytical software tool; which provides reproducible tools for the review and reporting of medical images. Cardiac VX can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice; multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization. A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point; distance; area; and volume measurement tools such as ejection; fraction; cardiac output; end-diastolic volume; end-systolic volume; and volume flow measurements. Semi-automatic tools are available for left ventricular contour detection; valve plane detection; vessel contour detection for flow analysis; signal intensity analysis for myocardium and infarct sizing measurement; and T2 Star analysis. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians. When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis. GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
Philips Medical Systems (Cleveland) Inc Apr-26-2014 Nuclear Gamma Cameras – Nuclear gamma cameras (ADAC Vertex Plus; ADAC Solus; ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System; Cleveland; OH 44143.Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel. Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.
Ortho-Clinical Diagnostics Apr-28-2014 VITROS Chemistry Products FS Diluent Pack 3 – VITROS Chemistry Products FS Diluent Pack 3; REF 680 1754; 3 x 45 mL; (D1)/15 mL (D2); IVD — Ortho-Clinical Diagnostics; Inc. Rochester; NY; 14626 Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or
Ortho-Clinical Diagnostics Apr-28-2014 VITROS Chemistry Products Specialty Diluent – VITROS Chemistry Products Specialty Diluent; REF 855 9825; 6 x 3 mL; IVD — Ortho-Clinical Diagnostics; Inc. Rochester; NY Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or d
Fisher Scientific Co Apr-28-2014 Fisherbrand – Fisherbrand Sterile Swabs; Calcium Alginate Fiber Tipped Aluminum Applicator Swab; .025 and .035 in Diameter; all lots; 100 per packFisherbrand Sterile Swabs; Calcium Alginate Fiber Tipped Plastic Applicator Swab; all lots; 100 per packFisherbrand Sterile Swabs; Calcium Alginate Fiber Tipped Wood Applicator Swab; all lots; 100 and 200 per packculture collection and industrial surfaces A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
Medtronic Neuromodulation Apr-29-2014 Activa PC; Activa RC; Active SC – Medtronic; Activa RC (37612); Activa PC (37601); Activa SC (37602);Activa SC (37603);Activa PC+S (37604); Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for mouvement disorders.All Restore; PrimeAdvanced and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore (Model 37711); the first released affected product was released to the market in April; 2005. There are a total of 19 affected device models; including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients. Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that; when enabled; allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
Medtronic Neuromodulation Apr-29-2014 RestoreUltra and RestoreSensor – Medtronic; Restore (37711); RestoreADVANCED (37713); RestoreADVANCED SureScan MRI (97713); RestoreSENSOR (37714); RestoreSENSOR SureScan MRI (97714);PrimeAdvanced SureScan MRI; (97702);RestoreULTRA (37712);RestoreULTRA SureScan MRI (97712)Itrel4 (37703);Itrel4 (37704);RestorePrime (37701);PrimeAdvanced (37702); Spinal cord Stimulation for chronic pain.All Restore; PrimeAdvanced and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore (Model 37711); the first released affected product was released to the market in April; 2005. There are a total of 19 affected device models; including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic; intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk Postlaminectomy pain Multiple back operations Unsuccessful disk surgery Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions Peripheral causalgia Epidural fibrosis Arachnoiditis or lumbar adhesive arachnoiditis Complex Regional Pain Syndrome (CRPS); Reflex Sympathetic Dystrophy (RSD); or Causalgia. A Medtronic implantable neurostimulation system is indicated for Medtronic DBSTM Therapy for Parkinson’s Disease – Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson’s Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced; levodopa-responsive Parkinson’s disease that are not adequately controlled with medication. A Medtronic implantable neurostimulation system is indicated for Medtronic DBS Therapy for Tremor – Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that; when enabled; allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
Medtronic Neuromodulation Apr-29-2014 Medtronic; External neurostimulator – Medtronic; External neurostimulator; ENS (37021) & ENS (37022).All Restore; PrimeAdvanced and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore (Model 37711); the first released affected product was released to the market in April; 2005. There are a total of 19 affected device models; including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients. Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that; when enabled; allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
Integra LifeSciences Corp. Apr-29-2014 Integra CUSA Excel+ Sterile Torque Wrench (23 kHz) – Integra CUSA Excel Disposable Wrench Sterile EO Rx Only Distributed by: Integra LifeSciences Corporation; Plainsboro; NJ 08536 USA. Integra LifeSciences (Ireland) Limited; IDA Business and Technical Park; Sragh; Tullamore; County Offaly; Ireland.The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field. The CUSA Excel+ system is intended for use in surgical procedures where fragmentation; emulsification and aspiration of soft tissue is desirable; including Neurosurgery; Gastrointestinal and Affiliated Organ Surgery; Urological Surgery; Plastic and Reconstructive Surgery; General Surgery; Orthopedic Surgery; Gynecological Surgery; Thoracic Surgery; Laparoscopic Surgery; and Thoracoscopic Surgery Integra identified through an investigation of complaint reports that some CUSA Excel+ Sterile 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
