BEUDAMED
    FDA Enforcement Class II Terminated

    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

    Recall: Z-1876-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1876-2018
    Event ID
    79834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 23, 2018
    Initiation Date
    December 19, 2017
    Classification Date
    May 15, 2018
    Termination Date
    October 19, 2021
    Address
    3150 NW 107th Ave, Doral, FL, 33172-2135, United States

    Description

    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

    Reason

    There is a possibility of the heparin line is occluded.

    Code Info

    Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.

    Distribution

    US Distribution to the states of : GA, NY, TN, TX.

    Quantity

    307,944 units.