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PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve
Date:10/31/2013

MONTVALE, N.J., Oct. 31, 2013 /PRNewswire/ -- On September 16, 2013 PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/ Water Valves, model OF-B194.  The valves were offered as a separate purchase for use with PENTAX GI Video Endoscopes (90i/90k series and i10/k10 series).  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.

Recalled OF-B194 Gas/ Water Valves were manufactured and distributed from August 2009 through July 2013. A total of 704 valves were distributed worldwide in the following regions: Europe/Middle East/Africa (EMEA) 300 valves, Asia Pacific (APAC) 278 valves, 24 valves in Japan, 26 valves in Canada and 76 valves in the United States. All units distributed in the United States and Worldwide have been recalled.

Products 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).

PENTAX Medical Company voluntarily recalled the OF-B194 Valve after becoming aware of a report to the Australia regulatory authority: A 74-year-old male patient admitted for routine Colonoscopy. Polypectomy performed in sigmoid on advancing to the caecum. Reached right side of colon and noticed Petechiae (discolouration due to minute haemor
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SOURCE PENTAX Medical Company
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