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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard

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 Class 2 Device Recall Halyardsee related information
Date Initiated by FirmSeptember 20, 2024
Date PostedNovember 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0394-2025
Recall Event ID 95515
Product Classification General surgery tray - Product Code LRO
ProductHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
Code Information GTIN: 10809160412930 Lot Number: 1604669
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactSAME
757-566-3510
Manufacturer 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
FDA Determined
Cause 2		Process control
ActionAvid 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.
Quantity in Commerce132 eaches
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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