Recall Z-0454-2025— 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 PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02. 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 PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
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.