Recall Z-0113-2016 ยท FEQ Pump, Air, Non-Manual, For Endoscope
Olympus Corporation of the Americas
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
| Date | Oct 8, 2015 (initiated Sep 11, 2015) |
| Status | Terminated |
| Reason | small puncture marks in a sterile package for an accessory to an Olympus device |
| Root cause | Process control |
| Action | A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices. |
| Quantity | 31060 |
| Distribution | US (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 Keymed (Medical & Industrial Equipment), Ltd., Sep 13, 2010 |