BEUDAMED
    FDA Recall Terminated

    Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.

    Recall: Z-1024-04 · Initiated June 8, 2004

    Recall

    Recall Number
    Z-1024-04
    Event Number
    29326
    Firm
    Medtronic Vascular
    FEI Number
    3001452571
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2004
    Posted
    July 20, 2004
    Terminated
    November 9, 2004
    Address
    3576 Unocal Pl, Santa Rosa, CA, 95403-1774

    Description

    Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.

    Reason

    medical device for which sterility may be compromised because of improper seal.

    Action

    A notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product.

    Distribution

    Product was distributed to 40 hospitals

    Quantity

    193 units