BEUDAMED
    FDA Enforcement Class II Ongoing

    Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

    Recall: Z-1083-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1083-2023
    Event ID
    91386
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    February 15, 2023
    Initiation Date
    November 17, 2022
    Classification Date
    February 6, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

    Reason

    Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

    Code Info

    a. MAJOR CDS-LF, Item Number: CDS983861D, Case UDI/GTIN: 40193489524353, Unit UDI/GTIN: 10193489524352, Lot Number: 22JDB004; b. BURN PACK-LF, Item Number: DYNJ0781678S, Case UDI/GTIN: 40193489226349, Unit UDI/GTIN: 10193489226348, Lot Number: 22IMC056; c. BURN PACK, Item Number: DYNJ82534, Case UDI/GTIN: 40195327198504, Unit UDI/GTIN: 10195327198503, Lot Number: 22HBI219; d. SMALL BURN, Item Number: DYNJ901793L, Case UDI/GTIN: 40193489955065, Unit UDI/GTIN: 10193489955064, Lot Number: 22KBB743,22IBH124

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

    Quantity

    100 cases (156 units)