BEUDAMED
    FDA Enforcement Class II Ongoing

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    Recall: Z-0910-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0910-2023
    Event ID
    91273
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bayer Medical Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2023
    Initiation Date
    November 30, 2022
    Classification Date
    January 6, 2023
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702, United States

    Description

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    Reason

    Black specks may be present on the packaged needles

    Code Info

    UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.

    Quantity

    2840 units