Recall Z-1041-2023— Carbon Medical Technologies, Inc.

Name: FDA recall Z-1041-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-16

Class II · Terminated

Class II FDA medical device recall by Carbon Medical Technologies, Inc., initiated 2022-12-16, terminated 2023-08-09. It names one FDA 510(k) clearance: K100994. Product: Mammotome MammoStar Biopsy Site Identified, REF STAR1401. 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..

Recalling firm: Carbon Medical Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-12-16
Terminated: 2023-08-09
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K100994 — PRELOADED TISSUE MARKER DEVICECarbon Medical Technologies, Inc.·cleared 2010-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.