BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Reported: October 6, 2021 Initiated: August 16, 2021 #Z-2565-2021
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."
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 484
- Distribution
- Domestic distribution nationwide. Product also distributed globally.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40. Recalled by Olympus Corporation of the Americas. Units affected: 484.
Why was this product recalled? ▼
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."
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2565-2021.
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