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Pentax Medical Company recalls PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Recalled August 27, 2014 · FDA recall Z-2290-2014 · Pentax Medical
Hazard
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health. · FDA Class II
Units
98 units US; 1108 units OUS
Sold at
Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
Description
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Product
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Manufacturer(s)
Pentax Medical Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →