BEUDAMED
    FDA Enforcement Class II Terminated

    T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. 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-2224-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2224-2016
    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

    T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. 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: 020-300198. Lot Number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D

    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

    3342 cases