BEUDAMED
    FDA Enforcement Class II Terminated

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    Recall: Z-0152-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0152-2022
    Event ID
    88741
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 27, 2021
    Initiation Date
    December 8, 2020
    Classification Date
    October 19, 2021
    Termination Date
    August 4, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    Reason

    The labeling was missing information on sterilization and prohibition of reuse.

    Code Info

    Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003

    Distribution

    Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates

    Quantity

    3420 devices