FDAFDA recall Z-3108-2026 · Sep 23, 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 are contaminated with Aspergillus penicillioides
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 I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot Number: 1658437 UDI: 10809160460481
- Quantity
- 288 units
- 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-3108-2026 · search recall number Z-3108-2026 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.