Recall Z-0983-2025 ยท KKX Drape, Surgical, Antimicrobial
O&M HALYARD, INC.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
| Date | Jan 17, 2025 (initiated Nov 26, 2024) |
| Status | Open, Classified |
| Reason | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. |
| Root 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: |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 Kimberly-Clark Corp., Mar 25, 2009 |