BEUDAMED
    FDA Recall Open, Classified

    Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

    Recall: Z-0053-2025 · Initiated August 28, 2024

    Recall

    Recall Number
    Z-0053-2025
    Event Number
    95338
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    FDE
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    August 28, 2024
    Posted
    October 10, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

    Reason

    CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.

    Action

    The recalling firm issued letters on and dated 8/28/2024 via first class mail and email. The letter explained the reason for recall and instructed the customer that nothing was to be returned to Medline. The customer is to request a sticker to be placed on affected kits instructing the user to remove the recalled component. The consignee is required to immediately check their stock for the affected item number and affected lot numbers which can be located within the recall portal and quarantine all affected product immediately. The consignee is to use the link and information in the letter to complete their response form. They are to list the quantity of affected product in inventory on the form and submit the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the user to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify their downstream customers of this communication.

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    72 kits