Olympus Corporation of the Americas Recall 89404
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
Olympus Corporation of the Americas Recall 89404 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0638-2022 |
| Event ID | 89404 |
| Event 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 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 295 units |
| Recall 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 |
| Device Classification | 20220223 |
| Device Code Info | All serial numbers. UDI: 04953170404047 |
| Center Classification Date | 20220211 |
| Recall Initiation Date | 20211213 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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