BEUDAMED
    FDA Enforcement Class II Ongoing

    Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.

    Recall: Z-2005-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-2005-2020
    Event ID
    85403
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Genicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 20, 2020
    Initiation Date
    June 27, 2018
    Classification Date
    May 14, 2020
    Address
    6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, 32792-6603, United States

    Description

    Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.

    Reason

    Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

    Code Info

    Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.

    Quantity

    1550