BEUDAMED
    FDA Enforcement Class II Terminated

    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

    Recall: Z-0787-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0787-2017
    Event ID
    75816
    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
    December 28, 2016
    Initiation Date
    November 18, 2016
    Classification Date
    December 18, 2016
    Termination Date
    October 23, 2017
    Address
    87 Venture Dr, N/A, Dover, NH, 03820-5914, United States

    Description

    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

    Reason

    Incorrect priming volume is printed on the device package.

    Code Info

    1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D

    Distribution

    US distribution in the state of CA

    Quantity

    31,500