BEUDAMED
    FDA Enforcement Class II Terminated

    20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.

    Recall: Z-2797-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2797-2018
    Event ID
    80460
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical de Mexico, S.A. de C.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    March 1, 2018
    Classification Date
    August 16, 2018
    Termination Date
    January 26, 2024
    Address
    Avenida Cuarzo 250, Ensenada, Ejido Maneadero, N/A, Mexico

    Description

    20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.

    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.

    Code Info

    Item Number 011-AM3002. a. Lot Number 3326545, UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545, Expiration Date 09/01/2021; b. Lot Number 3459161, UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161, Expiration Date 05/01/2022

    Distribution

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

    Quantity

    81 pouches