UPDATED 11/08/2013. Recall classified as Class I.
AUDIENCE: Risk Manager, Gastroenterology, Biomedical Engineering
ISSUE: 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.
BACKGROUND: 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).
Recalled OF-B194 Gas/ Water Valves were manufactured and distributed from August 2009 through July 2013. All units distributed in the United States and Worldwide have been recalled.
RECOMMENDATION: 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 Company distributed the product to Medical Facilities and PENTAX Sales Representatives/ Field Support Staff in the United States. All affected Medical Facilities in the United States have been notified of the action, have responded, and replacement OF-B194 Valves have been provided by PENTAX Medical Company.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178