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Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Class I - Dangerous
🏥 Medical Devices Recalled: December 16, 2022 Carbon Medical Technologies Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00858015005431, Lot Number 2201011A
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Product Codes/Lot Numbers:

UDI/DI 00858015005431, Lot Number 2201011A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1041-2023

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