Recall Z-3109-2026— AVID Medical, Inc.

Name: FDA recall Z-3109-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-14

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2026-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard IV Start Kit Non-Sterile REF: KRIV26-02. Reason: 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..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-14
Firm location: Toano, VA, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.