BEUDAMED
    FDA Enforcement Class II Terminated

    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

    Recall: Z-0832-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0832-2013
    Event ID
    64204
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 303 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    December 20, 2012
    Classification Date
    February 15, 2013
    Termination Date
    July 25, 2013
    Address
    3750 Torrey View Ct, N/A, San Diego, CA, 92130-2622, United States

    Description

    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

    Reason

    CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.

    Code Info

    Lot number 12055225

    Distribution

    Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.

    Quantity

    5,050 units