Halyard KRIV26-02_0003Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 22, 2026Class IOpen, Classified

   Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

   Z-3194-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Jul 22, 2026Class IIOpen, Classified

   Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

   Z-3260-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

3. Jul 14, 2026Class IIOpen, Classified

   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.

   Z-3109-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

4. Jul 14, 2026Class IOpen, Classified

   Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

   Z-3108-2026 · Root cause: Packaging process control · Recall details · FDA record ↗