FDA Enforcement
Class II
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
·
Reported October 14, 2015
Enforcement
- Recall Number
- Z-0113-2016
- Event ID
- 72242
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 14, 2015
- Initiation Date
- September 11, 2015
- Classification Date
- October 8, 2015
- Termination Date
- March 13, 2017
- Address
- PO Box 610, 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
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
Code Info
Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536
Distribution
US (nationwide) and Canada.
Quantity
31060