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Terminated

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

FDA Recall Z-2270-2018 · Posted None

Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeFET
Date Initiated2018-05-11
Date Terminated2020-05-05
Product Quantity68

Reason for Recall

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.

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K853585OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYSOlympus Corp. · 1986-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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