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Olympus Corporation of the Americas Recall 89942

Description: BF-3C160: EVIS EXERA Bronchovideoscope

Olympus Corporation of the Americas Recall 89942 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1047-2022
Event ID89942
Event DescriptionBF-3C160: EVIS EXERA Bronchovideoscope
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity1052 units
Recall ReasonBronchofiberscope 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 Classification20220518
Device Code InfoAll serial numbers. UDI: 04953170340031
Center Classification Date20220506
Recall Initiation Date20220308
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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