Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic m
FDA device recall Z-0329-2014 · posted 2013-11-15 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- 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.
- Action taken
- Notification letters were sent to customers on May 20, 2013.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FEQ
- Quantity affected
- 263
- Distribution
- Worldwide distribution: USA (nationwide) and the country of Canada.
- Date initiated
- 2013-05-20
- Date posted
- 2013-11-15
- Date terminated
- 2016-10-24
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (K100899) | Keymed (Medical & Industrial Equipment), Ltd. | 2010-09-13 |