FDA-Device2026-09-30Class IIPACKAGING DEFECT
Halyard IV START KIT NON-STERILE recalled for open or incomplete applicator seal
Nationwide distributionMedical devices
What this means
Halyard IV START KIT NON-STERILE kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. This affects 192 kits (4 cases) with lot number 1642214 and expiration date 7/31/2027. No injuries have been reported.
- Check if you have Halyard IV START KIT Model KRIV26-01 with lot number 1642214
- Do not use affected kits if the applicator packaging appears open or damaged
- Contact Halyard or your supplier for guidance on replacement or return
The agency's original wording
Hazard
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
192 kits (4 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: KRIV26-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3261-2026More AVID Medical recalls
- FDA-Device2026-09-30Halyard IV START KIT recalled for potentially unsealed ChloraPrep applicator packaging
- FDA-Device2026-09-30Halyard IV START KIT recalled for potential Aspergillus contamination
- 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.