BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 27, 2018

    Recall

    Recall Number
    Z-2005-2020
    Event Number
    85403
    Firm
    Genicon, Inc.
    FEI Number
    3002590791
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    June 27, 2018
    Address
    6869 Stapoint Ct, Ste 112, Winter Park, FL, 32792-6603

    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.

    Action

    A recall notification letter and updated Instructions for Use (IFU) labeling was sent to consignees on 5/1/2020. The firm is asking that labeling be provided to surgeons for them to read and to familiarize themselves with proper use of the specimen bag for multiple retrievals in the same patient. An Acknowlegement/Receipt Form was provided with response required.

    Distribution

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

    Quantity

    1550