BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1031-2023 · Initiated November 17, 2022

    Recall

    Recall Number
    Z-1031-2023
    Event Number
    91387
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    FDE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 17, 2022
    Posted
    January 27, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.

    Distribution

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

    Quantity

    57 cases (114 units)