BEUDAMED
    FDA Recall Terminated

    Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

    Recall: Z-2231-2021 · Initiated July 1, 2021

    Recall

    Recall Number
    Z-2231-2021
    Event Number
    88268
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    OJH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 1, 2021
    Terminated
    March 2, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

    Reason

    The kits may contain an expired component.

    Action

    Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.

    Distribution

    US Nationwide distribution in the states of MN, NE, and PA.

    Quantity

    286 kits total for all products