BEUDAMED
    FDA Recall Terminated

    CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device

    Recall: Z-0859-2009 · Initiated November 25, 2008

    Recall

    Recall Number
    Z-0859-2009
    Event Number
    50491
    Firm
    Fresenius Medical Care North America
    FEI Number
    3001451489
    Product Code
    KOC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 25, 2008
    Posted
    January 23, 2009
    Terminated
    September 24, 2009
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device

    Reason

    Port may crack and separate resulting in potential blood exposure/blood loss for the patient

    Action

    Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.

    Distribution

    Worldwide Distribution --- including USA and country of Canada.

    Quantity

    57 units