PENTAX Medical Gas/Water Valves, Model OF-B194: Recall
MedSun: Newsletter #89, November 2013
FDA MedWatch Safety Alert
PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/ Water Valves, 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, death, and bowel perforations requiring surgical repair. Customers who have OF-B194 PENTAX Gas/ Water Valves have been advised to immediately examine their inventory and quarantine and stop using the product subject to the recall.
PENTAX Medical Gas/Water Valves, Model OF-B194: Recall. FDA MedWatch Safety Alert.