Recall Z-0329-2014— Olympus America Inc.
Class II · Terminated
Class II FDA medical device recall by Olympus America Inc., initiated 2013-05-20, terminated 2016-10-24. It names one FDA 510(k) clearance: K100899. Product: Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.. Reason: 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..
- Recalling firm
- Olympus America Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-20
- Terminated
- 2016-10-24
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.