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Sources: EU EUDAMED, US FDA
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MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Recall
Terminated
·Linde Gas North America Llc
575 Mountain Ave
Attn Import Compliance Manager
New Providence NJ 07974·Product code CAN·March 8, 2013
Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
FDA Recall
Terminated
·Dynarex Corporation·Product code CAN·May 8, 2018
AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
FDA Recall
Terminated
·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009
Praxair Grab ''n Go Vantage unit, model PRX-9496.
FDA Recall
Terminated
·Praxair Distribution Inc.·Product code CAN·December 21, 2005
Praxair Grab ''n Go Vantage unit, model PRX-9495.
FDA Recall
Terminated
·Praxair Distribution Inc.·Product code CAN·December 21, 2005
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
FDA Recall
Terminated
·Praxair Inc.·Product code CAN·November 16, 2012
Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
FDA Recall
Terminated
·Precision Medical, Inc.·Product code CAN·October 8, 2015
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code CAN·April 7, 2014
AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
FDA Recall
Terminated
·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code CAN·January 31, 2015
Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml.
FDA Recall
Terminated
·Instituto Grifols, S.A. # 2 Can Guasch Street, Poligono Levante Parets Del Valles·Product code KPE·November 29, 2005
Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·December 6, 2012
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KNW·January 18, 2017
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·January 8, 2014
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KNW·June 18, 2015
ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code FPA·November 20, 2014
ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code FPA·November 20, 2014