Recall Z-3260-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02
| Date | Sep 23, 2026 (initiated Jul 22, 2026) |
| Status | Open, Classified |
| Reason | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. |
| Root cause | Packaging process control |
| Action | Consignees were initially notified on about 07/22/2026 via "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. They were informed that product may exhibit an open or incomplete seal on the packaging of the applicator. Consignees were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed. Consignees were notified again on about 08/20/2026 with an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" |
| Quantity | 816 kits (17 cases) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.