FDA-Device2026-09-30Class IIPACKAGING DEFECT

Halyard IV START KIT recalled for potentially unsealed ChloraPrep applicator packaging

OTHERNationwide distributionMedical devices

What this means

Halyard IV START KIT NON-STERILE convenience kits (model KRIV26-02) may have an open or incomplete seal on the BD ChloraPrep Clear applicator packaging. This affects 816 kits across 17 cases distributed nationwide. No injuries have been reported.

  • Check your Halyard IV START KIT for lot numbers 1658438, 1685838, 1699753, or 1706455.
  • Do not use kits with unsealed or damaged ChloraPrep applicator packaging.
  • Contact your supplier or Halyard/BD for replacement or disposal instructions.
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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
816 kits (17 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-3260-2026

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