FDA Recall
Terminated
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.
Recall: Z-0113-2016
·
Initiated September 11, 2015
Recall
- Recall Number
- Z-0113-2016
- Event Number
- 72242
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- FEQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 11, 2015
- Posted
- October 8, 2015
- Terminated
- March 13, 2017
- Address
- PO Box 610, 3500 Corporate Pkwy Center, Valley, PA, 18034-8229
Description
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.
Reason
small puncture marks in a sterile package for an accessory to an Olympus device
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.
Distribution
US (nationwide) and Canada.
Quantity
31060