FDA Enforcement
Class III
Ongoing
BiomarC EX Fiducial Marker System, Catalog Number 040165
Recall: Z-3161-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3161-2024
- Event ID
- 95179
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Carbon Medical Technologies, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- September 25, 2024
- Initiation Date
- July 26, 2024
- Classification Date
- September 17, 2024
- Address
- 1290 Hammond Rd, Saint Paul, MN, 55110-5867, United States
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.
Code Info
UDI/DI 00850002461305, Lot Number 2112355B
Distribution
US Nationwide distribution in the state of TN.
Quantity
25 boxes of 3 devices