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Brand Name: HALYARD recallZ-0983-2025 · O&M Halyard, Inc. · initiated Nov 26, 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 O&M Halyard, 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

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

FDA root cause category: Process control

What the company is doing

On November 26, 2024 URGENT VOLUNTARY RECALL letters were emailed to consignees. ACTIONS TO TAKE: " Immediately discontinue use of the Laparotomy Pack identified in APPENDIX 1. Please review your inventory, and segregate and quarantine all affected Packs. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " 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 above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " RETURN the completed Field Action Response Form to [email protected] as soon as possible even if you have no current product inventory. ADDITIONAL INFORMATION: Report any quality problems or adverse events associated with the products listed in this notification to [email protected]. Your assistance is appreciated and necessary to prevent any risk to patient health as a result of not following the field correction instructions. If you have any questions, please email [email protected] using the Event # FA-2024-031 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.

Recall details

Recall number
Z-0983-2025
Status
Open, Classified
Initiated by the company
Nov 26, 2024
Posted by the FDA
Jan 17, 2025
Recalling firm
O&M Halyard, Inc.
Quantity
1440 units
Product code
KKX
FDA submissions
K083234
Distribution
US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.

Product description

Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

Code information (models, lots, serial numbers)

Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28

Devices named in this recall

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

Other devices under the same FDA submission

8 devices cleared under K083234 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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