BEUDAMED
    FDA Recall Terminated

    Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY

    Recall: Z-2250-2016 · Initiated April 29, 2015

    Recall

    Recall Number
    Z-2250-2016
    Event Number
    74604
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 29, 2015
    Terminated
    November 3, 2016
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY

    Reason

    Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated because some light covers may have splits or holes, which may result in the transfer of microorganisms from the light handle into the patient wound.

    Action

    On 4/28/2015, URGENT PRODUCT RECALL NOTICE notifications were sent to the affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

    Distribution

    KS, IN, IA, KY, MT, SD

    Quantity

    483