FDA Recall
Open, Classified
BiomarC EX Fiducial Marker System, Catalog Number 040165
Recall: Z-3161-2024
·
Initiated July 26, 2024
Recall
- Recall Number
- Z-3161-2024
- Event Number
- 95179
- Firm
- Carbon Medical Technologies, Inc.
- FEI Number
- 3002619738
- Product Code
- IYE
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- July 26, 2024
- Posted
- September 17, 2024
- Address
- 1290 Hammond Rd, Saint Paul, MN, 55110-5867
Description
BiomarC EX Fiducial Marker System, Catalog Number 040165
Reason
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Action
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.
Distribution
US Nationwide distribution in the state of TN.
Quantity
25 boxes of 3 devices