BEUDAMED
    FDA Recall Terminated

    Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

    Recall: Z-0797-2020 · Initiated February 27, 2019

    Recall

    Recall Number
    Z-0797-2020
    Event Number
    82307
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    NNY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 27, 2019
    Terminated
    September 6, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

    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.

    Action

    The firm initiated the recall by letter on 02/27/2019. The notice stated that the device label incorrectly identified the products as sterile. Although incorrectly labeled as sterile, there is no requirement for sterility for its use. The firm requested that the distributors notify their customers. The firm did not request the return of the units, only to attach the notice to any recalled product in stock.

    Distribution

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

    Quantity

    13104 devices