BEUDAMED
    FDA Enforcement Class II Terminated

    107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    Recall: Z-1589-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1589-2015
    Event ID
    71028
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2015
    Initiation Date
    April 20, 2015
    Classification Date
    May 7, 2015
    Termination Date
    November 24, 2015
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    Reason

    ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

    Code Info

    Lot No. 3002665 3004236 2995225

    Distribution

    Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

    Quantity

    600 units