BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0931-2014 · Initiated January 16, 2014

    Recall

    Recall Number
    Z-0931-2014
    Event Number
    67326
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 16, 2014
    Posted
    February 4, 2014
    Terminated
    August 6, 2014
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    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.

    Action

    A customer notification letter and a distribution letter are dated 1/22/14 were sent to customers to inform them that CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230 may have a defect in the trifurcated component that could result in the component to leak. The letters inform the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclose, pre-addressed and postage paid, recall response card. Customers are instructed that once CareFusion receives the recall response card, the CareFusion Support Center will provide instructions for return of the affected lot number and replacement of the affected lot. Customers are instructed to contact CareFusion Support Center at (888) 562-6018, Customer advocacy at (888) 812-3266, [email protected], or technical support at (888) 812-3229.

    Distribution

    Nationwide in US and Canada

    Quantity

    9,550 units