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 00850002461305
    • Lot 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.