Carbon Medical Technologies, Inc. 2023-02-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1041-2023
Mammotome MammoStar Biopsy Site Identified, REF STAR1401 Recall
Issued February 8, 2023 · Carbon Medical Technologies, Inc.
In February 2023, Carbon Medical Technologies, Inc. recalled the Mammotome MammoStar Biopsy Site Identified, REF STAR1401, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Mammotome MammoStar Biopsy Site Identified, REF STAR1401 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Carbon Medical Technologies, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Carbon Medical Technologies, Inc.
- Category
- Health
- Recall date
- February 8, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of OHIO.
- Recall number
- FDA-Z-1041-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Carbon Medical Technologies, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.