BEUDAMED
    FDA Enforcement Class II Terminated

    T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    Recall: Z-2225-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2225-2016
    Event ID
    74437
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WalkMed Infusion, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 27, 2016
    Initiation Date
    June 14, 2016
    Classification Date
    July 18, 2016
    Termination Date
    December 1, 2016
    Address
    6555 S Kenton St Ste 304, N/A, Englewood, CO, 80111-6838, United States

    Description

    T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    Reason

    WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

    Code Info

    Product Number: 020-300204. Lot Number: 1406006, 1406008, 1406170, 1406171, 1406172, 1406173, 1406174, 1407125, 1407126, 1407127, 1407128, 1407129, 1408076, 1408077, 1409038D, 1409039D, 1409040D, 1410074D, 1410075D, 1410076D, 1410077D, 1411066D, 1411067D, 1412003D, 1412004D, 1412006D, 1412007D, 1501054D, 1501055D, 1501056D, 1501057D, 1501058D, 1502023D, 1502025D, 1502033D, 1503051D, 1503053D, 1506055D, 1506057D

    Distribution

    US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

    Quantity

    7529 cases