FDA-Device2026-09-30Class IPROCESSING DEFECT
Halyard IV START KIT recalled for potential Aspergillus contamination
What this means
Halyard IV START KIT NON-STERILE (Model KRIV26-02) convenience kits containing BD ChloraPrep Clear applicators may be contaminated with Aspergillus penicillioides, a fungus. The contamination was identified in 288 kits (6 cases) with lot number 1658437 and expiration date 1/31/2027.
- Check if you have model KRIV26-02 with lot number 1658437
- Do not use affected kits
- Contact AVID Medical or your supplier for instructions on return or disposal
- Report any adverse events to FDA MedWatch
The agency's original wording
Hazard
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
288 kits (6 cases)
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3194-2026More AVID Medical recalls
- FDA-Device2026-09-30Halyard IV START KIT NON-STERILE recalled for open or incomplete applicator seal
- FDA-Device2026-09-30Halyard IV START KIT recalled for potentially unsealed ChloraPrep applicator packaging
- FDA-Device2026-09-23AVID Medical Haylard biopsy kit recalled for sterility and quality issues with sodium chloride ampules
- FDA-Device2026-09-23AVID Medical Haylard 18G Single Shot EPI Tray recalled for sterility and quality issues
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
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