200 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
FDA Recall
Terminated
·Sun Med, LLC·Product code BTM·May 24, 2018
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID # 12-8710, 726-E; 86-722E, 726MM. Packaged under the name of Evergreen, Hospitak, and McKesson.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow. Product ID # 722-E, 86-722-E; 722MM. Packaged under the name of Hospitak and McKesson
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
FDA Recall
Terminated
·Westmed Inc·Product code BTM·June 22, 2010
XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTM·January 7, 2011
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.
FDA Recall
Terminated
·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DTM·June 14, 2013
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTM·October 1, 2013
OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTM·November 14, 2019