BiomarC EX Fiducial Marker System recall
BiomarC EX Fiducial Marker System, Catalog Number 040165
Why was BiomarC EX Fiducial Marker System recalled?
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI/DI 00850002461305, Lot Number 2112355B
- Product
- BiomarC EX Fiducial Marker System, Catalog Number 040165
- Recalling firm
- Carbon Medical Technologies, Inc.
- Quantity
- 25 boxes of 3 devices
- Distribution
- US Nationwide distribution in the state of TN.
- Recall date
- September 25, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)