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?
Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
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: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874
- 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
- 281
- Distribution
- U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX.
- Recall date
- April 23, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)