FDA recall Z-1041-2023

Carbon Medical Technologies, Inc. · Class II · device

Product

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

US Nationwide distribution in the state of OHIO.

Key facts

Status: Terminated
Initiation date: 2022-12-16
Report date: 2023-02-08
Termination date: 2023-08-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2023