Product Detail

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 Detail

Event Id 64856

Product Type Devices

Status Ongoing

Recalling Firm
Linde Gas North America Llc
City New Providence

State NJ
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-08

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide distribution.