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06-26-2013, 10:16 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
- Blog Entries
Recall: MEDICYCL-E- Lite Portable Oxygen System
Product Description 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.
Recall Number Z-1561-2013
Classification Class II
Code Info Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
Product Distributed Qty 52,264 units
Reason For Recall A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Event Id 64856
Product Type Devices
Linde Gas North America Llc
City New Providence
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution.