BEUDAMED
    FDA Enforcement Class II Terminated

    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

    Recall: Z-1275-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1275-2021
    Event ID
    87393
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sirtex Medical Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    February 22, 2021
    Classification Date
    March 18, 2021
    Termination Date
    April 17, 2023
    Address
    Centrecourt Business Park,, Unit D4, 25-27, Paul Street North, North Ryde, New South Wales, N/A, N/A, Australia

    Description

    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

    Reason

    There is a potential presence of particulate matter in the D-Vial.

    Code Info

    Lot Numbers: 1031234, 1031225, 1031227, 1031229

    Distribution

    US Nationwide distribution.

    Quantity

    3310