Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
FDA Recall Z-0329-2014 · Posted 2013-11-15
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Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeFEQ
Date Initiated2013-05-20
Date Terminated2016-10-24
Product Quantity263
Reason for Recall
There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.
Firm Action
Notification letters were sent to customers on May 20, 2013.
Root Cause
Component design/selection
Distribution Pattern
Worldwide distribution: USA (nationwide) and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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