BEUDAMED
    FDA Enforcement Class II Terminated

    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.

    Recall: Z-2043-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2043-2020
    Event ID
    84791
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    May 28, 2019
    Classification Date
    May 18, 2020
    Termination Date
    January 30, 2023
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.

    Reason

    Loose silicone particulate was found to be present on the shaft of the silicone catheters.

    Code Info

    GTIN 40080196848837 Model DYND11553 lot 287181201.

    Distribution

    US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

    Quantity

    0