Z-3161-2024 Class III Ongoing
FDA device recall Z-3161-2024 was initiated by Carbon Medical Technologies, Inc. on July 26, 2024 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 25 boxes of 3 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- July 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 boxes of 3 devices
Product Description
BiomarC EX Fiducial Marker System, Catalog Number 040165
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 Pattern
US Nationwide distribution in the state of TN.
Code Information
UDI/DI 00850002461305, Lot Number 2112355B