Laparotomy Pack (Halyard) – Manufacturing Additive (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Brand
O & M HALYARD, INC.
Lot Codes / Batch Numbers
Model No 88231, UDI-DI: 30680651882319, Lot Number: AC2335502D, Exp Date 21-12-28
Products Sold
Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
O & M HALYARD, INC. is recalling Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A due to Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026