Reported Sep 25, 2024 · Ongoing
BiomarC EX Fiducial Marker System, Catalog Number 040165
Carbon Medical Technologies, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carbon Medical Technologies, Inc. · 1290 Hammond Rd · Saint Paul, MN · 55110-5867
Is this the product you have?
- BiomarC EX Fiducial Marker System, Catalog Number 040165
- Lot codes and dates
UDI/DI 00850002461305Lot Number 2112355B
- Amount recalled
- 25 boxes of 3 devices
Where it was sold
- Nationwide
- TN
Why it was recalled
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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