Linde Gas North America Llc recalls MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplementa

Recalled June 26, 2013 · FDA recall Z-1561-2013 · Linde Gas North America

Hazard

A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. · FDA Class II

Units

52,264 units (1106 units)

Sold at

Nationwide distribution.

Description

A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.

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.

Manufacturer(s)

Linde Gas North America Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →