Channel Medsystems, Inc.: Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is

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

Details from the source

Reason for recall: 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 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. Quantity: 281 Lot/code info: Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874

UPC codes

00850008595035

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.