FDAMarch 20, 2025device
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstru...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
channel medsystemschannel
UPCs
00850008595035
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstru...2024-05-03
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