Recall Z-0263-2025— Westmed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Westmed, Inc., initiated 2024-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. Reason: 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..
- Recalling firm
- Westmed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-27
- Firm location
- Tucson, AZ, United States
Product description
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).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.