BEUDAMED
    FDA Recall Terminated

    Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area

    Recall: Z-0175-2007 · Initiated October 12, 2006

    Recall

    Recall Number
    Z-0175-2007
    Event Number
    36430
    Firm
    Asahi Medical Co., Ltd
    FEI Number
    1000599821
    Product Code
    FJI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2006
    Posted
    November 14, 2006
    Terminated
    November 28, 2007
    Address
    3100 Dundee Rd, Ste 201/202, Northbrook, IL, 60062-2437

    Description

    Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area

    Reason

    There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.

    Action

    Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.

    Distribution

    Nationwide

    Quantity

    100,000 for all models