Z-2005-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- June 27, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1550
Product 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 for Recall
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
Code Information
Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29