BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2421-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2421-2012
    Event ID
    63146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Asahi Kasei Medical Co., Ltd., Okatomi Plant
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    September 21, 2012
    Classification Date
    September 20, 2012
    Termination Date
    February 5, 2013
    Address
    4960 5 Chome Nakagawara Cho, Nobeoka-shi, N/A, Japan

    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.

    Code Info

    Lot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J

    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