BiomarC EX Fiducial Marker System, Catalog Number 040165
This recall is currently active, issued September 17, 2024. It was issued by Carbon Medical Technologies, Inc..
- Recall Initiated
- July 26, 2024
- Posted
- September 17, 2024
- Recall Number
- Z-3161-2024
- Quantity
- 25 boxes of 3 devices
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Distribution
US Nationwide distribution in the state of TN.
Lot / Code Info
UDI/DI 00850002461305, Lot Number 2112355B
Root Cause
Employee error
Action Taken
Carbon Medical Technologies issued an IMPORTANT" MEDICAL DEVICE RECALL notice to its sole consignee on 07/26/2024 via USPS certified mail and email. The notice explained the issue, the potential risk to the patient, and requested the the return of the affected product. Distributors were directed to notify their customers and to provide them with a copy of the MRI insert to be distributed to the patients.