Recall Z-2005-2020 ยท GCJ Laparoscope, General & Plastic Surgery
Genicon, Inc.
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.
| Date | Jun 27, 2018 |
| Status | Open, Classified |
| Reason | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. |
| Root cause | Labeling design |
| 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. |
| Quantity | 1550 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180579 | Ezee Retrieval Genicon, Inc., Mar 19, 2018 |