Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02

FDA device recall Z-0454-2025 · posted 2024-11-14 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

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

Action taken

Avid Medical issued Urgent: Voluntary Medical Device Recall letter via email on 9/20/24. Letter states reason for recall, health risk and action to take: If you received any of the batches/lots identified in APPENDIX 1, please review your inventory, and discard the entire kit. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified in Appendix 1 were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness. "Complete the attached Recall Response Form and return as soon as possible. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.

Root cause

Process control

Status

Open, Classified

Product code

OEZ

Quantity affected

56 eaches

Distribution

US Nationwide distribution.

Date initiated

2024-09-20

Date posted

2024-11-14

Location

Toano, VA