BEUDAMED
    FDA Enforcement Class II Terminated

    The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.

    Recall: Z-0199-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0199-2022
    Event ID
    88807
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bayer Medical Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    September 14, 2021
    Classification Date
    November 3, 2021
    Termination Date
    January 19, 2023
    Address
    1 Bayer Dr, N/A, Indianola, PA, 15051-9702, United States

    Description

    The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.

    Reason

    Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)

    Code Info

    Batch number: 8415317

    Distribution

    Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.

    Quantity

    6,950 units