Date Initiated by Firm | March 08, 2013 |
Date Posted | June 20, 2013 |
Recall Status1 |
Terminated 3 on February 03, 2015 |
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 NJ 07974
|
For Additional Information Contact | 908-508-2729 |
Manufacturer Reason for Recall | A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. |
FDA Determined Cause 2 | 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|