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Recall Observatory FDA recall evidence

Device product

Olympus JF-140F duodenoscopes (Model NumberJF-140F)

Z-2269-2018

May 11, 2018

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 79998
Status
Terminated
Classification
Class II
Quantity
994
Official record key
device-enforcement:Z-2269-2018

Official wording

Reason: 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.

Code information: All

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.