BiomarC EX Fiducial Marker System, Catalog Number 040165
Summary
The FDA issued a Class III for BiomarC EX Fiducial Marker System, Catalog Number 040165 by Carbon Medical Technologies, Inc.. Reason: This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient..
Details
Source
Device Recall
External ID
Z-3161-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
BiomarC EX Fiducial Marker System, Catalog Number 040165
Lot/Code Info: UDI/DI 00850002461305, Lot Number 2112355B
Quantity Affected: 25 boxes of 3 devices
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
US Nationwide distribution in the state of TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-26
Company
Saint Paul, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Carbon Medical Technologies, Inc. has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carbon Medical Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carbon Medical Technologies, Inc. have FDA actions?
Carbon Medical Technologies, Inc. has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3161-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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