BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0983-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0983-2025
    Event ID
    95920
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    November 26, 2024
    Classification Date
    January 17, 2025
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States

    Description

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

    Reason

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

    Code Info

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

    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.

    Quantity

    1440 units