BEUDAMED
    FDA Recall Terminated

    MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

    Recall: Z-0862-03 · Initiated May 7, 2003

    Recall

    Recall Number
    Z-0862-03
    Event Number
    26264
    Firm
    Guidant Corporation ACS
    FEI Number
    2024168
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 7, 2003
    Posted
    May 22, 2003
    Terminated
    December 1, 2004
    Address
    26531 Ynez Road, Temecula, CA, 92591-4628

    Description

    MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

    Reason

    Sterility compromised.

    Action

    The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.

    Distribution

    NATIONWIDE

    Quantity

    40