Brand Name: Cerene Cryotherapy Device Product Name recall
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The…
Why was Brand Name: Cerene Cryotherapy Device Product Name recalled?
Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: All non-expired lots manufactured through February 2024 101635693, 101635694, 101635695, 101635696, 102211255, 102211256, 102211257, 102211258, 102887363, 102887364, 103151029, 103151030, 103151031, 103151032, 103489753, 103489754, 103489755, 103489756, 103489757, 103925402, 104008714, 104008715, 104521903, 104521904, 104521905, 104521906, 104521907, 104808352, 104808353, 105418198, 105733204, 105733205
- Product
- Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The…
- Recalling firm
- Channel Medsystems, Inc.
- Quantity
- 1772
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and the country of Netherlands.
- Recall date
- May 29, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)