Z-0983-2025Class II

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

Name: Z-0983-2025 Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product...
Creator: O&m Halyard, Inc.
Published: 2024-11-26
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2024-11-26 / Open, Classified / root cause: manufacturing process

FDA source

O&M HALYARD, INC. began a recall of Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A on 2024-11-26. FDA classified it as Class II and gives the reason as "Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0983-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-26
Posted: 2025-01-17
Recalling firm: O&M Halyard, Inc.
Product: Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1440 units
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 codes and lots: Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0983-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0983-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17

Product code KKX

K083234Class IIKimberly-Clark Kc100 Surgical Drapes, Model Kc 100, Kimberly-Clark Kc100 Surgical Equipment Covers, Model Kc 100Kimberly-Clark Corp. / cleared 2009-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)