BEUDAMED
    FDA Enforcement Class II Terminated

    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

    Recall: Z-0933-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0933-2018
    Event ID
    79318
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 21, 2018
    Initiation Date
    October 3, 2017
    Classification Date
    March 9, 2018
    Termination Date
    January 6, 2020
    Address
    87 Venture Dr, Dover, NH, 03820-5914, United States

    Description

    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

    Reason

    The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.

    Code Info

    AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)

    Distribution

    US Distribution.

    Quantity

    21350