Home / Recalls / Carbon Medical Technologies, Inc. / Z-1041-2023

Z-1041-2023 Class II Terminated

Recalled by Carbon Medical Technologies, Inc. — Saint Paul, MN

Recall Details

Product Type: Devices
Report Date: February 8, 2023
Initiation Date: December 16, 2022
Termination Date: August 9, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 550 devices

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.

Distribution Pattern

US Nationwide distribution in the state of OHIO.

Code Information

UDI/DI 00858015005431, Lot Number 2201011A