BEUDAMED
    FDA Recall Terminated

    VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.

    Recall: Z-0434-05 · Initiated December 7, 2004

    Recall

    Recall Number
    Z-0434-05
    Event Number
    30637
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2004
    Posted
    January 26, 2005
    Terminated
    November 19, 2008
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.

    Reason

    Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.

    Action

    Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.

    Distribution

    Distributed to 57 accounts throughout the United States and three international accounts.

    Quantity

    153 units