BEUDAMED
    FDA Enforcement Class II Terminated

    AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

    Recall: Z-1484-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1484-2017
    Event ID
    76607
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    February 20, 2017
    Classification Date
    March 18, 2017
    Termination Date
    April 22, 2019
    Address
    87 Venture Dr, Dover, NH, 03820-5914, United States

    Description

    AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

    Reason

    Incorrect priming volume printed on the device package.

    Code Info

    1610092D 1611091D 1612068D 1612074D

    Distribution

    US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV

    Quantity

    30,700