BEUDAMED
    FDA Enforcement Class II Terminated

    AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.

    Recall: Z-0813-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0813-2014
    Event ID
    67255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    January 7, 2014
    Classification Date
    January 23, 2014
    Termination Date
    November 3, 2014
    Address
    87 Venture Drive, Dover, NH, 03820-5914, United States

    Description

    AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.

    Reason

    Defective component may cause extension sets to leak.

    Code Info

    Lot Number: 1306034, 1307011

    Distribution

    US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH

    Quantity

    3850