Recall Z-3109-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
| Date | Sep 4, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area. |
| Root cause | Packaging process control |
| Action | On July 14, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an Urgent Medical Device Recall to affected consignees via email. I Avid Medical Inc. requested consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified. 1a. Discontinue use of the BD ChloraPrep" Clear - 1 mL and FREPP" Clear 1.5 mL Applicators. 1b. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affec |
| Quantity | 98 Kits |
| Distribution | US Nationwide distribution in the state of NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.