Recall Z-2531-2025 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
| Date | Sep 5, 2025 (initiated Aug 4, 2025) |
| Status | Open, Classified |
| Reason | Potential for open header bag seals, compromising sterility. |
| Root cause | Nonconforming Material/Component |
| Action | Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided. |
| Quantity | 228 units |
| Distribution | US Nationwide distribution in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.