Recall Z-2531-2025— AVID Medical, Inc.

Name: FDA recall Z-2531-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-04

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2025-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.. Reason: Potential for open header bag seals, compromising sterility..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-04
Firm location: Toano, VA, United States

Product description

Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

Reason for recall

Potential for open header bag seals, compromising sterility.

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