FDA-Device2026-09-16Class IIPACKAGING DEFECT
Halyard IV Start Kit Non-Sterile recalled for compromised seal integrity
What this means
Halyard IV Start Kit Non-Sterile (REF: KRIV26-02) convenience kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkles in the paper lidding that may breach the seal. This compromises sterility assurance of the applicators. 98 kits in lot 1658438 (expiration 7/31/2026) were distributed nationally.
- Check if you have Halyard IV Start Kit REF: KRIV26-02, lot 1658438
- Do not use kits with wrinkled paper lidding or visible seal damage
- Contact your medical supplier or Halyard for guidance on replacement or return
The agency's original wording
Hazard
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of NE.
Affected count
98 Kits
Manufactured in
9000 Westmont Dr, 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-3109-2026Also reported as
More AVID Medical recalls
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