Reported Jun 26, 2013 · Terminated
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental…
Linde Gas North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Linde Gas North America Llc · 575 Mountain Ave · New Providence, NJ · 07974
Is this the product you have?
- 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.
- Lot codes and dates
- ModelManufacturer's #M70500037
- Cataogue Number109855
- Lot numbers25/07 48/06 20/03
- Amount recalled
- 52,264 units (1106 units)
Where it was sold
- Nationwide
Why it was recalled
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
This product could cause temporary or reversible health problems — stop using it.
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