BEUDAMED
    FDA Recall Terminated

    RAD SOURCE RS 3000 Blood Irradiator Three Bag Option

    Recall: Z-0745-04 · Initiated June 1, 2002

    Recall

    Recall Number
    Z-0745-04
    Event Number
    26998
    Firm
    Rad-Source Technologies, Inc. 20283 State Rd. 7 Suite 107 Boca Raton FL 33498
    FEI Number
    3002459090
    Product Code
    MOT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 1, 2002
    Posted
    July 20, 2004
    Terminated
    May 3, 2012

    Description

    RAD SOURCE RS 3000 Blood Irradiator Three Bag Option

    Reason

    The firm completed a cooling system retrofit to preclude overheating and failure.

    Action

    The firm e-mailed a notification on May 9, 2002 to its consignees giving them instructions on using additional radiation indictors to assure that the blood units were correctly irradiated. They also initiated a cooling tube retrofit of all units on that date and this was completed on 8/13/2002.

    Distribution

    Units were distributed to 20 blood banks and transfusion services in WI, KS, IN, MI, GA, NC, WA, NE, FL, IN, TX, MD, Washington DC, SC, and NM.

    Quantity

    20