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Recall Observatory FDA recall evidence

Device product

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Z-1041-2023

December 16, 2022

Class II

Product summary

Firm
Carbon Medical Technologies, Inc.
Event
Event 91419
Status
Terminated
Classification
Class II
Quantity
550 devices
Official record key
device-enforcement:Z-1041-2023

Official wording

Reason: 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.

Code information: UDI/DI 00858015005431, Lot Number 2201011A

Distribution pattern: US Nationwide distribution in the state of OHIO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.