BEUDAMED
    FDA Enforcement Class II Terminated

    MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.

    Recall: Z-0927-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-0927-2017
    Event ID
    75736
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bayer Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    November 7, 2016
    Classification Date
    February 7, 2017
    Termination Date
    October 18, 2017
    Address
    1 Bayer Dr, N/A, Indianola, PA, 15051-9702, United States

    Description

    MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.

    Reason

    Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.

    Code Info

    Device Listing # D053816

    Distribution

    Nationwide Distribution

    Quantity

    178,982 (86,172 units in U.S.)