Z-0983-2025 Class II Ongoing
FDA device recall Z-0983-2025 was initiated by O&M HALYARD, INC. on November 26, 2024 and is designated Class II. Reason for recall: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. The recall status is ongoing. Affected quantity: 1440 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- November 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1440 units
Product Description
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Reason for Recall
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Distribution Pattern
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.
Code Information
Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28