BEUDAMED
    FDA Recall Terminated

    Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU

    Recall: Z-0351-04 · Initiated December 30, 2003

    Recall

    Recall Number
    Z-0351-04
    Event Number
    28027
    Firm
    Toray Marketing & Sales (America), Inc
    FEI Number
    3001632632
    Product Code
    FJI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 30, 2003
    Posted
    January 14, 2004
    Terminated
    February 3, 2004
    Address
    140 Cypress Station Dr, Ste 210, Houston, TX, 77090-1627

    Description

    Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU

    Reason

    Potential loose header (end cap) on hollow fiber dialyzers.

    Action

    Firm notified all consignees by phone call on 1/2/2004 and 1/5/2004. Firm is also notifying all consignees by letter with a response form, sent by certified mail.

    Distribution

    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.

    Quantity

    252 units