FDA-Device2018-06-27Class II
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
Olympus Corporation of the Americas
Hazard
Issuance of validated, new reprocessing procedures. 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
68
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2270-2018Don't want to check this manually?
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