BEUDAMED
    FDA Enforcement Class III Terminated

    Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

    Recall: Z-0796-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0796-2020
    Event ID
    82307
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    February 27, 2019
    Classification Date
    January 10, 2020
    Termination Date
    September 6, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

    Reason

    The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

    Code Info

    GTIN 24026704549836 Lot Numbers: 74A1800914, 74A1801938, 74A1802088, 74B1800292, 74B1800362, 74B1801603, 74C1800428, 74C1801090, 74C1801172, 74C1802127, 74E1800684, 74E1802780, 74F1800358, 74F1801409, 74F1801915, 74G1800046, 74G1800893, 74G1801165, 74H1700889, 74H1701630, 74H1702627, 74J1701765, 74J1702485, 74K1700319, 74L1700073, 74L1700304

    Distribution

    ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

    Quantity

    39456 devices