Recall Z-3194-2026— AVID Medical, Inc.

Class I · Ongoing

Class I FDA medical device recall by AVID Medical, Inc., initiated 2026-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.. Reason: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides..

Recalling firm
AVID Medical, Inc.
Classification
Class I
Status
Ongoing
Initiated
2026-07-22
Firm location
Toano, VA, United States

Product description

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

Reason for recall

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

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