Westmed, Inc.: Device Recall

Recall #Z-0263-2025 · 09/27/2024

Class II: Risk

Recall Details

Recall Number: Z-0263-2025
Classification: Class II
Product Type: Device
Recalling Firm: Westmed, Inc.
Status: Ongoing
Date Initiated: 09/27/2024
Location: Tucson, AZ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50,050 units

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.

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).

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.