Reported Feb 8, 2023 · Terminated
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Carbon Medical Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Mammotome MammoStar Biopsy Site Identified, REF STAR1401
- Lot codes and dates
UDI/DI 00858015005431Lot Number 2201011A
- Amount recalled
- 550 devices
Where it was sold
- Nationwide
- OH
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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