Olympus Corporation of the Americas Recall 89942
Description: BF-MP160F: EVIS EXERA Bronchofibervideoscope
Olympus Corporation of the Americas Recall 89942 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1048-2022 |
Event ID | 89942 |
Event Description | BF-MP160F: EVIS EXERA Bronchofibervideoscope |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Quantity | 292 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: 04953170289064 |
Center Classification Date | 20220506 |
Recall Initiation Date | 20220308 |
Recalling Firm | Olympus Corporation of the Americas |
Initial Notification | Letter |
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