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U.S. Department of Health and Human Services

Class 2 Device Recall Westmed Flex Extender

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 Class 2 Device Recall Westmed Flex Extendersee related information
Date Initiated by FirmSeptember 27, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0263-2025
Recall Event ID 95453
Product Classification Connector, airway (extension) - Product Code BZA
Product1) 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).
Code Information Catalog Number: S6411P UDI-DI codes: Each: 00709078012488 Case: 10709078012485 Lot Numbers: 0004294660 0004289136 0004291318 0004295361 Catalog Number: 7 5132 UDI-DI codes: Each: 00709078008405 Case: 10709078008402 Lot Numbers: 0004289133 0004289134 0004289135 0004289735 0004289736 0004289737 0004290327 0004290328 0004291315 0004291316 0004291317 0004291790 0004291791 0004292272 0004292273 0004292275 0004292717 0004293127 0004294432 0004294433 0004295069 0004295358 0004295458
FEI Number 1000374126
Recalling Firm/
Manufacturer		 Westmed, Inc.
5580 S Nogales Hwy Ste 170
Tucson AZ 85706-3333
For Additional Information ContactRob Yamashita
616-259-8400
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce50,050 units
DistributionU.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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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