BEUDAMED
    FDA Enforcement Class II Terminated

    Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

    Recall: Z-1193-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1193-2018
    Event ID
    79301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    February 15, 2018
    Classification Date
    March 26, 2018
    Termination Date
    October 31, 2018
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

    Reason

    Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

    Code Info

    Lot Number 73H1600207

    Distribution

    KS

    Quantity

    12 units