BEUDAMED
    FDA Recall Terminated

    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.

    Recall: Z-2811-2018 · Initiated March 1, 2018

    Recall

    Recall Number
    Z-2811-2018
    Event Number
    80460
    Firm
    ICU Medical de Mexico, S.A. de C.V. Avenida Cuarzo 250 Ensenada Ejido Maneadero Mexico
    FEI Number
    3003807466
    Product Code
    FMG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2018
    Terminated
    January 26, 2024

    Description

    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.

    Reason

    ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.

    Action

    ICU Medical notified customers of the recall on about 03/01/2018 via URGENT: Medical Device Recall Notification. The notification informed customers that this was an update and expansion to previously initiated recall. Instructions included to inspect inventory for affected devices, arrange for the return of affected devices, and complete and return the Urgent Medical Device Recall Notification Response Form to [email protected].

    Distribution

    US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.

    Quantity

    100 pouches