BEUDAMED
    FDA Recall Terminated

    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

    Recall: Z-2199-2011 · Initiated April 19, 2011

    Recall

    Recall Number
    Z-2199-2011
    Event Number
    58596
    Firm
    Fresenius Kabi, LLC
    FEI Number
    3007344667
    Product Code
    LKN
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    April 19, 2011
    Posted
    May 16, 2011
    Terminated
    December 6, 2011
    Address
    8635 154th Ave NE, Redmond, WA, 98052-3564

    Description

    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

    Reason

    Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.

    Action

    Fresenius Kabi sent a "Urgent Notification" letter dated May 6, 2011, to the affected consignees they are recalling the Operating Manual for the Fresinius AS104-Blood Cell Separator. The Red Blood Cell (RBC) sets have been recalled according to recall number Z-0616-2011, and will permanently not be used with the AS 104 Blood Cell Separator Device. The RBC set was never approved by the FDA according to Warning Letter (Reference # GEN1001508) dated 31 January 2011. The customers are being instructed to complete the self addressed postage pre-paid " Product Response Card." Place a check mark next to the disposition choice used. Fresenius plans to send the revised Operating Manual and a notification letters to consignees at the end of April 2011. Consignees who have questions about this recall can call the firm at 1-425-242-2074.

    Distribution

    Nationwided Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, NC, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VT, and WI.

    Quantity

    158 units