Medtronic Neuromodulation - Medtronic Synchromed II Implantable Drug Infusion Pump - Class 2 Recall
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006). (Source: Me...
Source: Medical Device Recalls - March 4, 2018 Category: Medical Devices Source Type: alerts
ZOLL Medical Corporation - Portable Critical Care Ventilator - Class 2 Recall
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biologic...
Source: Medical Device Recalls - March 2, 2018 Category: Medical Devices Source Type: alerts
Sorin Group Deutschland GmbH - CP5 Centrifugal Pump - Class 2 Recall
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2018 Category: Medical Devices Source Type: alerts
Physio-Control, Inc. - LIFEPAK 20e DEFIBRILLATOR/MONITOR - Class 1 Recall
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2018 Category: Medical Devices Source Type: alerts
Orthoscan, Inc. - OrthoScan HD (10000004) - Class 2 Recall
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2018 Category: Medical Devices Source Type: alerts
Orthoscan, Inc. - OrthoScan HD (10000001) - Class 2 Recall
Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2018 Category: Medical Devices Source Type: alerts
Orthoscan, Inc. - OrthoScan FD Mini CArm - Class 2 Recall
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2018 Category: Medical Devices Source Type: alerts
Orthoscan, Inc. - OrthoScan Mobile DI Mini CArm - Class 2 Recall
Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2018 Category: Medical Devices Source Type: alerts
PROACTIV EMERGENCY BLEMISH RELIEF (Benzoyl Peroxide) Cream [THE PROACTIV COMPANY LLC]
Updated Date: Dec 15, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 15, 2017 Category: Drugs & Pharmacology Source Type: alerts
REDICARE EMERGENCY FIRST AID EYEWASH (Emergency First Aid Eyewash) Irrigant [Redicare LLC]
Updated Date: Nov 13, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 13, 2017 Category: Drugs & Pharmacology Source Type: alerts
Spectranetics Corporation - Bridge Balloon Catheter - Class 1 Recall
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2017 Category: Medical Devices Source Type: alerts
Vortran Medical Technology 1, Inc - VORTRAN Automatic Resuscitator, VARPlus - Class 2 Recall
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2017 Category: Medical Devices Source Type: alerts
Vortran Medical Technology 1, Inc - VORTRAN Automatic Resuscitator - Class 2 Recall
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2017 Category: Medical Devices Source Type: alerts
Newport Medical Instruments Inc - Newport Medical HT70 and HT70 Plus Ventilators - Class 1 Recall
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators 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 Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable f...
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts
PROACTIV EMERGENCY BLEMISH RELIEF (Benzoyl Peroxide) Cream [The Proactiv Company, LLC]
Updated Date: Apr 4, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 4, 2017 Category: Drugs & Pharmacology Source Type: alerts
