Class I Medical Device Recall: Pentax Medical Company, PENTAX Gas/Water Valve, Model OF-B194

The OF-B194 Valve has been found to have a manufacturing defect which may prevent users from turning off the CO2 gas flow during an endoscopic procedure with the potential for serious hazard to the patient, including peritonitis, perforations, sepsis,...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news