BEUDAMED
    FDA Recall Terminated

    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

    Recall: Z-0512-2019 · Initiated November 19, 2018

    Recall

    Recall Number
    Z-0512-2019
    Event Number
    81599
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FMG
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    November 19, 2018
    Terminated
    June 5, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

    Reason

    Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924

    Action

    Smiths Medical notified customers on about 11/19/2018 via email with the attached "URGENT MEDICAL DEVICE RECALL NOTICE." Distributors were instructed to immediately notify customers to whom they have distributed affected product to of the Recall Notice. They were also instructed to follow the following steps: 1. Locate affected product in your possession by referring to the attached Response Form. This form identifies specific affected product that Smiths Medical shipped to your facility. 2. Determine the number of affected devices in your possession and complete the attached Response Form within 10 days of receipt, returning it to [email protected]. This form must be returned even if you do not have any affected product in your possession. 3. Upon receipt of the completed Response Form, a shipping label will be issued to you for use in returning your affected product for processing. Package the affected products securely and include a copy of the completed Response Form inside each box, ensuring boxes are sealed and labeled with your facility name prior to shipping. Credit will be processed when your completed Response Form is received and once returned affected products have been processed.

    Distribution

    The potentially affected products were shipped to customers in the US, Canada, and Mexico.

    Quantity

    2,425 devices