Z-0638-2022 Class II Terminated
FDA device recall Z-0638-2022 was initiated by Olympus Corporation of the Americas on December 13, 2021 and is designated Class II. Reason for recall: 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 cyc… The recall status is terminated (terminated December 26, 2023). Affected quantity: 295 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 23, 2022
- Initiation Date
- December 13, 2021
- Termination Date
- December 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 295 units
Product 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 for Recall
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
Distribution Pattern
Nationwide
Code Information
All serial numbers. UDI: 04953170404047