BEUDAMED
    FDA Recall Terminated

    Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250

    Recall: Z-0711-03 · Initiated March 20, 2003

    Recall

    Recall Number
    Z-0711-03
    Event Number
    25844
    FEI Number
    3002095335
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2003
    Posted
    April 9, 2003
    Terminated
    July 2, 2004
    Address
    Boston Scientific Scimed One Scimed Place Maple, Grove, MN, 55311-1566

    Description

    Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250

    Reason

    The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.

    Action

    Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.

    Distribution

    The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.

    Quantity

    31 stents