Summary
The FDA issued a Class II for BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 by Olympus Corporation of the Americas. Reason: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings.
Details
Source
Device Recall
External ID
Z-2565-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Lot/Code Info: All serial numbers
Quantity Affected: 484
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
Domestic distribution nationwide. Product also distributed globally.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-16
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2565-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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