BEUDAMED
    FDA Recall Terminated

    AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161

    Recall: Z-2442-2019 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2442-2019
    Event Number
    83567
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    EZY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 19, 2019
    Terminated
    April 23, 2020
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161

    Reason

    Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..

    Action

    Boston Scientific contacted customer via the sales representative on July 19, 2019. The removal letter was given to the customer by the sales representative. The letter states reason for recall, health risk and Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific

    Distribution

    MN

    Quantity

    1 unit