BEUDAMED
    FDA Enforcement Class II Terminated

    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

    Recall: Z-1114-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1114-2019
    Event ID
    81866
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon U.S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 17, 2019
    Initiation Date
    December 6, 2018
    Classification Date
    April 9, 2019
    Termination Date
    May 12, 2020
    Address
    2750 Morris Rd Ste A200, N/A, Lansdale, PA, 19446-6083, United States

    Description

    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

    Reason

    DualStop Caps defect causing leaks in affected product

    Code Info

    Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD

    Distribution

    US Nationwide distribution.

    Quantity

    339,800