BF-1T60 OES Bronchofiberscope recall: Labeling Error
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
Why was BF-1T60 OES Bronchofiberscope 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."
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers
- Product
- BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 350
- Distribution
- Domestic distribution nationwide. Product also distributed globally.
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)