Product Safety Recalls

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Olympus Corporation of the Americas Recall 88562

Description: BF-N20 OES Bronchofiberscope, Model No. BF-N20

Olympus Corporation of the Americas Recall 88562 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2564-2021
Event ID88562
Event DescriptionBF-N20 OES Bronchofiberscope, Model No. BF-N20
Product TypeDevices
DistributionDomestic distribution nationwide. Product also distributed globally.
Quantity377
Recall ReasonThe firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Device Classification20211006
Device Code InfoAll serial numbers
Center Classification Date20210924
Recall Initiation Date20210816
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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