FDAFDA recall Z-3109-2026 · Sep 16, 2026
AVID Medical, Inc.: Halyard IV Start Kit Non-Sterile REF: KRIV26-02 recall
Recall found
Product
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Number:1658438 7/31/2026 UDI: 10809160460481
- Quantity
- 98 Kits
- Distribution
- US Nationwide distribution in the state of NE.
- Recalling firm
- AVID Medical, Inc., Toano, VA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-14
Source: openFDA enforcement record Z-3109-2026 · search recall number Z-3109-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.