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Carbon Medical Technologies, Inc. recalls Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Recalled February 8, 2023 · FDA recall Z-1041-2023 · Carbon Medical Technologies
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. · FDA Class II
Units
550 devices
Sold at
US Nationwide distribution in the state of OHIO.
Description
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.
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Manufacturer(s)
Carbon Medical Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →