Z-2565-2021 Class II Terminated
FDA device recall Z-2565-2021 was initiated by Olympus Corporation of the Americas on August 16, 2021 and is designated Class II. 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." The recall status is terminated (terminated March 11, 2024). Affected quantity: 484.
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
- 484
Product Description
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
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