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Terminated

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

FDA Recall Z-1041-2023 · Posted 2023-01-30

Recalling FirmCarbon Medical Technologies, Inc.
Recall StatusTerminated
Product CodeNEU
Date Initiated2022-12-16
Date Terminated2023-08-09
Product Quantity550 devices

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.

Firm Action

Carbon Medical Technologies sent an IMPORTANT: MEDICAL DEVICE RECALL notice by email to its sole consignee on 12/16/2022. The notice explained the issue and requested that the consignee perform the following actions: "Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify you customers and notify them at once of this product recall." "Affected product should be returned to: Regulatory Affairs, Carbon Medical Technologies, Inc., 1290 Hammond Road, St. Paul, MN 55110-5959" "If you have any question, comments, or concerns please contact Customer Support at +1 888-207-2062. You may also email [email protected]."

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of OHIO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100994PRELOADED TISSUE MARKER DEVICECarbon Medical Technologies, Inc. · 2010-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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