Class 2 Device Recall HALYARD

• Date Initiated by Firm: November 26, 2024
• Date Posted: January 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0983-2025
• Recall Event ID: 95920
• 510(K)Number: K083234
• Product Classification: Drape, surgical - Product Code KKX
• Product: Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
• Code Information: Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
• Recalling Firm/ Manufacturer: O&M HALYARD, INC.; 9120 Lockwood Blvd; Mechanicsville VA 23116-2015
• Manufacturer Reason for Recall: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
• FDA Determined Cause: Process control
• Action: On November 26, 2024 URGENT VOLUNTARY RECALL letters were emailed to consignees. ACTIONS TO TAKE: " Immediately discontinue use of the Laparotomy Pack identified in APPENDIX 1. Please review your inventory, and segregate and quarantine all affected Packs. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " 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. ADDITIONAL INFORMATION: Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com. Your assistance is appreciated and necessary to prevent any risk to patient health as a result of not following the field correction instructions. If you have any questions, please email GM-OMRA_RECALLS@owens-minor.com using the Event # FA-2024-031 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.
• Quantity in Commerce: 1440 units
• Distribution: US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.
• 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