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 West

FDA device recall Z-0263-2025 · posted 2024-10-30 · Open, Classified

Recall details

Recalling firm

Westmed, Inc.

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.

Action taken

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 the firm documents the amount of product customers have on hand for return and/or destruction. It will also allow for documentation of customers' receipt of this letter. 3. In addition, if product was further distributed, please identify customers/consignees, and notify them of this product removal. Further notification may be enhanced by including a copy of this removal notification letter. If any assistance contacting your customers is needed, let Recalling Firm know and they will communicate this removal to them on your behalf. 4. Once customers return and/or confirm destruction of the affected product(s), new replacement product will be sent. If replacement products are needed to be sent urgently, call directly at 1 800 433 2797 and Recall Firm will make every effort to accommodate your needs. 5. Make sure that all affected personnel in your organization are informed of this removal notice. For any questions regarding this field action, call AirLife at 1 800 433 2797, or e mail productquality@myairlife.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BZA

Quantity affected

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

Date initiated

2024-09-27

Date posted

2024-10-30

Location

Tucson, AZ