BEUDAMED
    FDA Enforcement Class II Ongoing

    Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO

    Recall: Z-1076-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1076-2023
    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. ENDOSCOPY-LF b. SEPTO/ENDO

    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. ENDOSCOPY-LF, Item Number: DYNJ22890M, Case UDI/GTIN: 40193489766487, Unit UDI/GTIN: 10193489766486, Lot Number: 22JBM081; b. SEPTO/ENDO, Item Number: DYNJ902831D, Case UDI/GTIN: 40193489231671, Unit UDI/GTIN: 10193489231670, Lot Number: 22JBP701;

    Distribution

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

    Quantity

    20 cases (72 units)