Linde Gas Recalls MEDICYL-e Portable Oxygen Systems Due to Valve Defect
Linde Gas North America is recalling MEDICYL-e Portable Oxygen Systems because some units may have misapplied valve flow knobs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could affect the delivery of supplemental oxygen. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Linde Gas North America is recalling a number of MEDICYL-e Portable Oxygen Systems. The recall is being conducted because some of these devices may have misapplied valve flow knobs.
The MEDICYL-e is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. It is designed for emergency use when administered by properly trained personnel for oxygen deficiency and resuscitation, and for other medical applications with a prescription. The device is MRI safe and MRI-compatible for use during MR Imaging for MRI systems up to 3.0 T.
The recall affects 52,264 units, with 1,106 units distributed nationwide. The affected model is Manufacturer's #M70500037, Catalogue Number 109855. The specific lot numbers involved are 25/07, 48/06, and 20/03. Consumers should check their devices for these identifiers and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Linde Gas North America Llc
Distribution
Distributed nationwide across the United States.
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