BEUDAMED
    FDA Recall 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 · Initiated November 7, 2016

    Recall

    Recall Number
    Z-0927-2017
    Event Number
    75736
    Firm
    Bayer Healthcare
    FEI Number
    2520313
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2016
    Terminated
    October 18, 2017
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    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.

    Action

    Bayer mailed an Urgent Medical Device Field Safety Notice dated November 3. 2017 to affected customers to inform them of the issue. Customers were asked to immediately quarantine unused product and resume use once the qualified in-line filter is received or to request a RGA (Return Goods Authorization) number to return the product. Customers were asked to complete the response form indicating if their institution does or does not have affected product and return the form via fax to 1-412-406-0941. Customers with questions were instructed to contact the Customer Care team at 1-800-633-7231, opt 2. For questions regarding this recall call 412-767-2400. On December 5, 2016, the recalling firm sent a new letter indicating the inline filter has been successfully tested and that they have qualified a compatible in-line filter to be used with the Patient Administrative Set (PAS) that will allow you to resume use of your Intego system.

    Distribution

    Nationwide Distribution

    Quantity

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