—#164186

Product

Olympus JF-160F duodenoscopes (Model NumberJF-160F)

FDA product code: FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K853585
Affected lot / code info: All

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Firm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2018-05-11
Terminated: 2020-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.