BEUDAMED
    FDA Enforcement Class II Terminated

    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

    Recall: Z-1636-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1636-2018
    Event ID
    79752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon U.S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    February 28, 2018
    Classification Date
    May 4, 2018
    Termination Date
    February 19, 2019
    Address
    2750 Morris Rd Ste A200, N/A, Lansdale, PA, 19446-6083, United States

    Description

    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

    Reason

    Potential friction holes may affect the sterility of the product.

    Code Info

    Lot Numbers: 17F001D & 17K038D UDI: 08498840004814

    Distribution

    Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

    Quantity

    16520 total products