BEUDAMED
    FDA Recall Terminated

    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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-2042-2020 · Initiated May 28, 2019

    Recall

    Recall Number
    Z-2042-2020
    Event Number
    84791
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    EZL
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    May 28, 2019
    Terminated
    January 30, 2023
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.

    Action

    Medline Industries, Inc. sent formal letters with response forms to each consignee affected via 1st class mail on May 28, 2019. Each consignee was also provided with a response form to return via fax or email. The recalled product that is will be quarantined at the corporate office located at Three Lakes Drive, Northfield, IL 60093-2753 pending destruction.

    Distribution

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

    Quantity

    330