Recall Z-2520-2025 ยท KKX Drape, Surgical, Antimicrobial
O&M HALYARD INC
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
| Date | Sep 4, 2025 (initiated Jul 17, 2025) |
| Status | Open, Classified |
| Reason | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| Root 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 complaint |
| Quantity | 1316 |
| Distribution | Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX. |
| 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 |