BEUDAMED
    FDA Enforcement Class II Ongoing

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    Recall: Z-0296-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0296-2021
    Event ID
    86431
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    THREAD COUNSEL INC DBA LAWS OF MOTION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    September 17, 2020
    Classification Date
    October 25, 2020
    Address
    175 Varick St, N/A, New York, NY, 10014-4604, United States

    Description

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    Reason

    Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.

    Code Info

    Lots 1 -47

    Distribution

    Distributed to accounts in New York

    Quantity

    2.4 million