BEUDAMED
    FDA Enforcement Class II Ongoing

    Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

    Recall: Z-1031-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1031-2023
    Event ID
    91387
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    November 17, 2022
    Classification Date
    January 27, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

    Reason

    Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

    Code Info

    Item Number: CDS980894A, UDI/GTIN Case: 40889942401292, UDI/GTIN Each: 10889942401291, Lot Numbers: 22HMD613, 22JMB665

    Distribution

    US Nationwide distribution in the states of AR, MD, WA, WI.

    Quantity

    57 cases (114 units)