BEUDAMED
    FDA Recall Terminated

    Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.

    Recall: Z-0960-03 · Initiated May 9, 2003

    Recall

    Recall Number
    Z-0960-03
    Event Number
    26361
    Firm
    Cobe Cardiovascular, Inc
    FEI Number
    1718850
    Product Code
    DTN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 9, 2003
    Posted
    July 2, 2003
    Terminated
    July 8, 2003
    Address
    14401 West 65th Way, Arvada, CO, 80004

    Description

    Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.

    Reason

    Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

    Action

    All consignees were contacted by telephone on 05/09/2003, followed by a letter.

    Distribution

    MN, NE, OK

    Quantity

    60 units