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U.S. Department of Health and Human Services

Class 2 Device Recall MEDICYCLE Lite Portable Oxygen System

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 Class 2 Recall
MEDICYCLE Lite Portable Oxygen System
see related information
Date Posted June 20, 2013
Recall Status1 Open
Recall Number Z-1561-2013
Recall Event ID 64856
Product Classification Regulator, Pressure, Gas Cylinder - Product Code CAN
Product 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.
Code Information Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
Recalling Firm/
Manufacturer
Linde Gas North America Llc
575 Mountain Ave
Attn Import Compliance Manager
New Providence, New Jersey 07974
Manufacturer Reason
for Recall
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, The Linde Group, sent a "Voluntary Medical Device Recall" letter dated June 21, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to view the enlarged photo on the reverse side of the notice for guidance. If you or your customers have a Unit with lot number 25/07, then please return it with the Product to your local LifeGas fill center as soon as possible. No other lot numbers are subject to this removal action. Customers with questions should contact Linde's Customer Care Center at 1-866-LIFEGAS (543-3427).
Quantity in Commerce 52,264 units (1106 units)
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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