BEUDAMED
    FDA Enforcement Class II Ongoing

    Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

    Recall: Z-1689-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1689-2021
    Event ID
    87802
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vygon U.S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 9, 2021
    Initiation Date
    April 15, 2021
    Classification Date
    May 28, 2021
    Address
    2750 Morris Rd Ste A200, Lansdale, PA, 19446-6681, United States

    Description

    Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

    Reason

    Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection

    Code Info

    Lot Number: 203373129 Exp. Date: June 30, 2022

    Distribution

    US Nationwide distribution in the state of PA.

    Quantity

    8,320 units