Recall Z-2269-2018— Olympus Corporation of the Americas

Name: FDA recall Z-2269-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-11

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2018-05-11, terminated 2020-05-05. It names one FDA 510(k) clearance: K853585. Product: Olympus JF-140F duodenoscopes (Model NumberJF-140F). 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Terminated: 2020-05-05
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K853585 — OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYSOlympus Corp.·cleared 1986-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.