Recall Z-2005-2020
Genicon, Inc. · initiated June 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
Reason for recall
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-2005-2020
- Initiated
- June 27, 2018
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 1550
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
- Recalling firm
- Genicon, Inc., Winter Park, FL