BEUDAMED
    FDA Enforcement Class II Terminated

    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

    Recall: Z-1482-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1482-2017
    Event ID
    76440
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    February 20, 2017
    Classification Date
    March 16, 2017
    Termination Date
    October 29, 2018
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

    Reason

    CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.

    Code Info

    Lot No. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810

    Distribution

    Nationwide Distribution

    Quantity

    12,850 units