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Halyard FOOT ANKLE PACK - Medical convenience kits recallZ-0398-2025 · AVID Medical, Inc. · initiated Sep 20, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Process control

What the company is doing

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 [email protected].

Recall details

Recall number
Z-0398-2025
Status
Open, Classified
Initiated by the company
Sep 20, 2024
Posted by the FDA
Nov 14, 2024
Recalling firm
AVID Medical, Inc.
Quantity
72 eaches
Product code
LRO
Distribution
US Nationwide distribution.

Product description

Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02

Code information (models, lots, serial numbers)

GTIN: 10809160394595 Lot Number: 1589794

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95515).

Sources and updates

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