FDA Enforcement
Class III
Terminated
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Recall: Z-0458-2021
·
Reported November 25, 2020
Enforcement
- Recall Number
- Z-0458-2021
- Event ID
- 86596
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Steris Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 25, 2020
- Initiation Date
- October 7, 2020
- Classification Date
- November 16, 2020
- Termination Date
- July 14, 2021
- Address
- 5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States
Description
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Reason
Potential for cleaning solution intrusion into endoscope
Code Info
Distributed from May 23, 2017 to June 30, 2020
Distribution
Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
Quantity
293 units:248 units (USA); 45 units OUS