Mammotome MammoStar Biopsy Site Identified, REF STAR1401
FDA Recall #Z-1041-2023 — Class II — December 16, 2022
Product Description
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Reason for Recall
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.
Recalling Firm
Carbon Medical Technologies, Inc. — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
550 devices
Distribution
US Nationwide distribution in the state of OHIO.
Code Information
UDI/DI 00858015005431, Lot Number 2201011A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated