FDA Enforcement
Class II
Terminated
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Recall: Z-0638-2022
·
Reported February 23, 2022
Enforcement
- Recall Number
- Z-0638-2022
- Event ID
- 89404
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 23, 2022
- Initiation Date
- December 13, 2021
- Classification Date
- February 11, 2022
- Termination Date
- December 26, 2023
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Reason
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
Code Info
All serial numbers. UDI: 04953170404047
Distribution
Nationwide
Quantity
295 units