FDA-Device2026-09-23Class IPROCESSING DEFECT
Halyard IV START KIT NON-STERILE recalled for fungal contamination in applicators
What this means
Halyard IV START KIT convenience kits (Lot 1658437) contain applicators contaminated with Aspergillus penicillioides, a fungus. The contamination was found in BD ChloraPrep Clear and FREPP Clear applicators included in the kits. This is a Class I recall affecting 288 units distributed in Nebraska.
- Stop using kits from Lot 1658437 (UDI: 10809160460481) immediately.
- Contact Halyard Medical or your distributor for instructions on return or replacement.
- Do not use the contaminated applicators on patients.
The agency's original wording
Hazard
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of NE.
Affected count
288 units
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3108-2026Also reported as
- FDA-Device2026-09-30Halyard IV START KIT recalled for potential Aspergillus contamination
More AVID Medical recalls
- FDA-Device2026-09-30Halyard IV START KIT NON-STERILE recalled for open or incomplete applicator seal
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- 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
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