BEUDAMED
    FDA Enforcement Class II Terminated

    108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326

    Recall: Z-1592-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1592-2015
    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

    108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326

    Reason

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

    Code Info

    Lot No. 2997915 2997919 2997920 2998568 2998569 3001232 3001233 3001234 3004257 3015880 3015881 3019519 3020159

    Distribution

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

    Quantity

    13,800 units