Official recall notice

FDA DeviceClass IINotable

FDA Recall: Halyard IV Start Kit Non-Sterile REF: KRIV26-02

Recall date
2026-09-16
FDA class
Class II

Why it was recalled

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.

Product description

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.

Affected products

Lot Number:1658438 7/31/2026 UDI: 10809160460481

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