BEUDAMED
    FDA Enforcement Class II Ongoing

    Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

    Recall: Z-1073-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1073-2023
    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. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

    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. MINOR/BREAST BIOPSY-LF, Item Number: DYNJS3035, Case UDI/GTIN: 40884389421926, Unit UDI/GTIN: 10884389421925, Lot Number: 22IBK248,22IBB171,22HBM446; b. BREAST BIOPSY-LF, Item Number: DYNJT1911D, Case UDI/GTIN: 40888277808967, Unit UDI/GTIN: 10888277808966, Lot Number: 22JBG862,22HBV267

    Distribution

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

    Quantity

    237 cases (1,242 units)