Class 2 Device Recall Orthopedic Pack, Model: 8804112 AC2424601B 09/02/2029 Universal Pack, Model: 7716506

• Date Initiated by Firm: July 17, 2025
• Date Posted: September 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2520-2025
• Recall Event ID: 97394
• 510(K)Number: K083234
• Product Classification: Drape, surgical - Product Code KKX
• Product: Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
• Code Information: Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
• Recalling Firm/ Manufacturer: O&M HALYARD INC; 1220 Old Alpharetta Rd Ste 320; Alpharetta GA 30005-3946
• For Additional Information Contact: 471-602-2974
• Manufacturer Reason for Recall: Surgical drape packs may have open seals, which may compromise the sterility of the product.
• FDA Determined Cause: Process control
• Action: On 7/17/2025, Field Action Customer Notifications were emailed to customers who were asked to do the following: 1) DESTROY or DISCARD the product available in your inventory per the facility's standard disposal procedure for surgical packs. 2) COMMUNICATE this Field Action to staff to ensure awareness of it. 3) If any of the affected lot identified above was further distributed, please ensure all end-users are appropriately notified of this Field Action and maintain records of effectiveness. 4) Any adverse events associated with the use of the affected product should be reported to complaints@owens-minor.com. 5) RETURN the completed Field Action Response Form to GM-OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. 6) If credit is requested, please get contact with the Customer Service team and send email to GM-OMRA_RECALLS@owens-minor.com. If you have any questions, please email GM-OMRA_RECALLS@owens-minor.com using the Event # FA-2025-015 in the header of the response
• Quantity in Commerce: 1316
• Distribution: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = KKX