FDA-Device2023-02-08Class II
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Carbon Medical Technologies, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of OHIO.
Affected count
550 devices
Manufactured in
1290 Hammond Rd, N/A, Saint Paul, MN, United States
Products
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2023Don't want to check this manually?
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