BEUDAMED
    FDA Recall Terminated

    Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.

    Recall: Z-1491-06 · Initiated August 4, 2006

    Recall

    Recall Number
    Z-1491-06
    Event Number
    36168
    Firm
    Cobe Cardiovascular, Inc
    FEI Number
    1718850
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 4, 2006
    Posted
    September 9, 2006
    Terminated
    December 28, 2011
    Address
    14401 W 65th Way, Arvada, CO, 80004-3524

    Description

    Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.

    Reason

    Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.

    Action

    Consignees were notified by telephone and e-mail on 08/04/2006.

    Distribution

    Nationwide, including VA facilities in CA and OH

    Quantity

    8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06