Olympus Corporation of the Americas Recall 89942
Description: BF-3C160: EVIS EXERA Bronchovideoscope
Olympus Corporation of the Americas Recall 89942 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1047-2022 |
| Event ID | 89942 |
| Event Description | BF-3C160: EVIS EXERA Bronchovideoscope |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 1052 units |
| Recall Reason | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization |
| Device Classification | 20220518 |
| Device Code Info | All serial numbers. UDI: 04953170340031 |
| Center Classification Date | 20220506 |
| Recall Initiation Date | 20220308 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
| Similar To |