BEUDAMED
    FDA Recall Terminated

    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

    Recall: Z-2421-2012 · Initiated September 21, 2012

    Recall

    Recall Number
    Z-2421-2012
    Event Number
    63146
    Firm
    Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan
    FEI Number
    3007340888
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 21, 2012
    Posted
    September 20, 2012
    Terminated
    February 5, 2013

    Description

    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

    Reason

    Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.

    Action

    AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.

    Distribution

    REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany

    Quantity

    80,208 units