BEUDAMED
    FDA Enforcement Class III Terminated

    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

    Recall: Z-1974-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1974-2019
    Event ID
    81954
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2019
    Initiation Date
    January 14, 2019
    Classification Date
    July 15, 2019
    Termination Date
    December 13, 2022
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

    Reason

    The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

    Code Info

    GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.

    Quantity

    105426 US eaches