Reported Nov 6, 2024 · Ongoing
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The…
Westmed, 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: Westmed, Inc. · 5580 S Nogales Hwy Ste 170 · Tucson, AZ · 85706-3333
Is this the product you have?
- 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).
- Lot codes and dates
- Catalog NumberS6411P
- UDI-DI codesEach: 00709078012488
- Case10709078012485
- Lot Numbers0004294660 0004289136 0004291318 0004295361
- Catalog Number7 5132
- UDI-DI codesEach: 00709078008405
- Case10709078008402
- Lot Numbers
00042891330004289134000428913500042897350004289736000428973700042903270004290328000429131500042913160004291317000429179000042917910004292272000429227300042922750004292717000429312700042944320004294433000429506900042953580004295458
- Amount recalled
- 50,050 units
Where it was sold
Why it was recalled
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
This product could cause temporary or reversible health problems — stop using it.
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