BEUDAMED
    FDA Enforcement Class II Terminated

    104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    Recall: Z-1590-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1590-2015
    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

    104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 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. 2992752 2997916 3004237 3019517 3026353

    Distribution

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

    Quantity

    1,500 units