Home / Recalls / Medical Devices
Olympus Corporation of the Americas recalls Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Recalled June 27, 2018 · FDA recall Z-2269-2018 · Olympus Corporation of the Americas
Hazard
Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection. · FDA Class II
Units
994
Sold at
Nationwide
Description
Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
Product
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →