Reported Jun 14, 2017 · Terminated
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
ConvaTec, Inc.
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: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
- Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
- Lot codes and dates
Lot Number 102153102339102941103176103453103718103919104471105034105282105427105567105996106960108658112024112530
- Amount recalled
- 816,709
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was recalled
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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