FDAFDA · Food and drugs·Recall number Z-3161-2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
Published September 25, 2024 · Recall initiated: July 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Carbon Medical Technologies, Inc.
- Distributor
- US Nationwide distribution in the state of TN.
- Lot
- UDI/DI 00850002461305, Lot Number 2112355B
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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