BEUDAMED
    FDA Recall Terminated

    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

    Recall: Z-1250-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1250-2022
    Event Number
    90135
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    FDE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 3, 2022
    Terminated
    May 31, 2024
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    Description

    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

    Reason

    Potential for the tip of the electrode to detach during use.

    Action

    The firm sent out a recall notification on 05/03/2022 via email as well as the supplier's recall notice and label template to be used to label affected kits in the consignee's inventory. The recall notification letter informs the consignee to check their inventory, quarantine affected units, label affected kits, reply to the response form, and notify customers that were sent affected product. End users are to remove the affected items and discard them.

    Distribution

    Distributed to North Carolina.

    Quantity

    125 units