Z-0983-2025 Class II Ongoing

Recalled by O&M HALYARD, INC. — Mechanicsville, VA

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