BEUDAMED
    FDA Enforcement Class II 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 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0624-2016
    Event ID
    72701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    January 20, 2016
    Initiation Date
    March 30, 2015
    Classification Date
    January 8, 2016
    Termination Date
    February 4, 2016
    Address
    3150 Nw 107th Ave, N/A, Miami, FL, 33172, United States

    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.

    Code Info

    Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.

    Distribution

    US Distribution to states of: TN and NJ.

    Quantity

    1,484 pieces.