BEUDAMED
    FDA Enforcement Class II Terminated

    CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).

    Recall: Z-0756-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0756-2021
    Event ID
    86825
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lidco Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 6, 2021
    Initiation Date
    November 19, 2020
    Classification Date
    December 30, 2020
    Termination Date
    September 26, 2022
    Address
    16 Orsman Road, N/A, London, N/A, N/A, United Kingdom

    Description

    CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).

    Reason

    The expiration date on labeling is incorrect.

    Code Info

    Model CM 50-001-01, Lot 11103786 (expiration: 04/26/2023) and Lot 11090135 (expiration: 02/2023)

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait.

    Quantity

    40 packs (5 each per pack)