Channel Medsystems, Inc. is recalling approximately 281 Cerene Cryotherapy Devices (Model FGS-7000) used for endometrial ablation to reduce menstrual bleeding. The recall was issued because a gasket inside the device may fail to seal properly, which can cause liquid nitrous oxide to leak or drip from the handle during or after a treatment. No incidents or injuries have been reported to date.
A leak of liquid nitrous oxide from the bottom of the device handle poses a risk of localized cold-related injuries, such as cryoburns, to either the patient or the healthcare professional performing the procedure.
Single-use, disposable, and provided sterile.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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