BEUDAMED
    FDA Enforcement Class II Terminated

    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

    Recall: Z-0931-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0931-2014
    Event ID
    67326
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    January 16, 2014
    Classification Date
    February 4, 2014
    Termination Date
    August 6, 2014
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

    Reason

    CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

    Code Info

    Trifurcated Extension Set, Model No. ME 1224, Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002 Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.

    Distribution

    Nationwide in US and Canada

    Quantity

    9,550 units