BEUDAMED
    FDA Enforcement Class II Terminated

    Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

    Recall: Z-1277-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1277-2015
    Event ID
    70143
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Infusion Inc dba Trucare Biomedix-USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    October 10, 2014
    Classification Date
    March 13, 2015
    Termination Date
    June 23, 2015
    Address
    6356 Manor Ln, Suite 103, South Miami, FL, 33143-4960, United States

    Description

    Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

    Reason

    Several complaints regarding the IV sets leaking at the Y site.

    Code Info

    Model # MS721, Lot # 20111115.

    Distribution

    Distributed in the states of TX, IL, MA, OH, CA, and GA.

    Quantity

    62,700 IV sets