BEUDAMED
    FDA Recall Terminated

    Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201

    Recall: Z-0735-03 · Initiated March 17, 2003

    Recall

    Recall Number
    Z-0735-03
    Event Number
    25812
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    GBM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2003
    Posted
    April 17, 2003
    Terminated
    March 7, 2016
    Address
    1 Boston Scientific Place, Natick, MA, 01760

    Description

    Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201

    Reason

    Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use

    Action

    Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.

    Distribution

    Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa

    Quantity

    293 boxes (20 units/box)