BEUDAMED
    FDA Recall Terminated

    Custom heart lung perfusion packs

    Recall: Z-0265-06 · Initiated October 6, 2005

    Recall

    Recall Number
    Z-0265-06
    Event Number
    33842
    Firm
    Cobe Cardiovascular, Inc
    FEI Number
    1718850
    Product Code
    DTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2005
    Posted
    December 2, 2005
    Terminated
    August 5, 2011
    Address
    14401 W 65th Way, Arvada, CO, 80004-3524

    Description

    Custom heart lung perfusion packs

    Reason

    One way valve in the heart lung pack assembly may be missing.

    Action

    Consignees notified by letter on 10/06/2005.

    Distribution

    Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.

    Quantity

    21,512 units