BEUDAMED
    FDA Enforcement Class II Terminated

    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, 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-2722-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2722-2017
    Event ID
    77560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    May 30, 2017
    Classification Date
    July 11, 2017
    Termination Date
    September 20, 2024
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, 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.

    Code Info

    Lot No. 3040897, 3085194, 3100137, 3125469, 3136083, 3284928, 3288396, 3309182. Item No. AM6100

    Distribution

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

    Quantity

    900 units