Recall Z-0409-2025— AVID Medical, Inc.

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2024-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29. Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions.

Recalling firm
AVID Medical, Inc.
Classification
Class II
Status
Ongoing
Initiated
2024-09-20
Firm location
Toano, VA, United States

Product description

Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

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