Home / Recalls / Olympus Corporation of the Americas / Z-2568-2021

Z-2568-2021 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 6, 2021
Initiation Date
August 16, 2021
Termination Date
March 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1030

Product Description

BF-P60 OES Bronchofiberscope, Model No. BF-P60

Reason for Recall

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Distribution Pattern

Domestic distribution nationwide. Product also distributed globally.

Code Information

All serial numbers

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