BiomarC EX Fiducial Marker System, Catalog Number 040165
Class I - Dangerous 🏥 Medical Devices
Recalled: July 26, 2024 Carbon Medical Technologies Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: UDI/DI 00850002461305, Lot Number 2112355B
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Carbon Medical Technologies, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
BiomarC EX Fiducial Marker System, Catalog Number 040165
Product Codes/Lot Numbers:
UDI/DI 00850002461305, Lot Number 2112355B
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3161-2024
Related Recalls
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Carbon Medical Technologies
Class I - Dangerous
The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.