FDA-Device2018-06-27Class II
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
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.
Sold states
Nationwide
Affected count
994
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2269-2018More Olympus Corporation of the Americas recalls
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