Recall Z-0263-2025 ยท BZA Connector, Airway (Extension)
Westmed, Inc.
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).
| Date | Oct 30, 2024 (initiated Sep 27, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 09/27/2024, A written customer recall notification in the form of an URGENT: Customer Recall Letter was provided to consignees that were sent the affected lots of Westmed Flex Extenders. To address the potential patient safety risk, AirLife statement to distributors and end-users of Westmed Flex Extenders is: Customer immediate actions: 1. Review the list of affected products. Examine their inventory for the mentioned lot(s). No other lots are affected. 2. Complete and return the attached Response Form via email to: productquality@myairlife.com as soon as possible. This will enable that th |
| Quantity | 50,050 units |
| Distribution | U.S.: AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA, and WV O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.