BEUDAMED
    FDA Recall Terminated

    NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.

    Recall: Z-0624-2016 · Initiated March 30, 2015

    Recall

    Recall Number
    Z-0624-2016
    Event Number
    72701
    Firm
    Nipro Medical Corporation
    FEI Number
    1000132332
    Product Code
    FJK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2015
    Posted
    January 8, 2016
    Terminated
    February 4, 2016
    Address
    3150 Nw 107th Ave, Miami, FL, 33172

    Description

    NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.

    Reason

    Blood foaming was found during evaluation of the product.

    Action

    NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use. Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to [email protected] / 305.599.7174x249.

    Distribution

    US Distribution to states of: TN and NJ.

    Quantity

    1,484 pieces.