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Valve Recalled Due to Switch Defect; Potential for Gastrointestinal Injury


The Pentax Gas/Water Valve, Model OF-B194, was recalled because the valve has been found to have a manufacturing defect which may prevent users from turning off the carbon dioxide gas flow during an endoscopic procedure with the potential for serious hazard to the patient, including peritonitis, perforations, sepsis, bowel perforations requiring surgical repair, and death.

 

The Pentax Gas/ Water Valve, Model OF-B194, was used with upper gastrointestinal endoscopes to deliver carbon dioxide, a non-explosive gas, into a body cavity. The product was manufactured from April 2009 through August 2013 and distributed from April 2009 through September 2013. The product can be identified by the model number (OF-B194) stamped on the valve. Corrected valves have a circle before the model number (O OF-B194).

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

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