BEUDAMED
    FDA Recall Terminated

    ASY, Brat Pack Procedure Set

    Recall: Z-1072-05 · Initiated June 22, 2005

    Recall

    Recall Number
    Z-1072-05
    Event Number
    32561
    Firm
    Cobe Cardiovascular, Inc
    FEI Number
    1718850
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2005
    Posted
    August 3, 2005
    Terminated
    July 27, 2006
    Address
    14401 W 65th Way, Arvada, CO, 80004-3524

    Description

    ASY, Brat Pack Procedure Set

    Reason

    Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

    Action

    Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005

    Distribution

    Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.

    Quantity

    2912 units