BEUDAMED
    FDA Recall Terminated

    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..

    Recall: Z-2720-2017 · Initiated May 30, 2017

    Recall

    Recall Number
    Z-2720-2017
    Event Number
    77560
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    FMG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 30, 2017
    Posted
    June 26, 2017
    Terminated
    September 20, 2024
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..

    Reason

    The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.

    Action

    Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: [email protected].

    Distribution

    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.

    Quantity

    70 units