FDA recall Z-2269-2018

Product

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-05-11

Report date

2018-06-27

Termination date

2020-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2269-2018