—#210612

Product

Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02

FDA product code: OKV — Obstetrical Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: GTIN: 10809160420072 Lot Number: 1610500

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: AVID Medical, Inc.
Address: 9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-09-20
Posted by FDA: 2024-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.