O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Softwa…

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

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.

• FDA enforcement recordOfficial FDA database entry for Z-0983-2025
• FDA 510(k) clearance · K083234The device's official FDA premarket clearance record
• FDA device classification · KKXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4370The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find O&M HALYARD, INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.