Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Summary
The FDA issued a Class II for Mammotome MammoStar Biopsy Site Identified, REF STAR1401 by Carbon Medical Technologies, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-1041-2023
Action Date
2023-02-08
Status
Terminated
Category
device
Product Description
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Lot/Code Info: UDI/DI 00858015005431, Lot Number 2201011A
Quantity Affected: 550 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.
Distribution
US Nationwide distribution in the state of OHIO.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-16
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Carbon Medical Technologies, Inc. has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carbon Medical Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carbon Medical Technologies, Inc. have FDA actions?
Carbon Medical Technologies, Inc. has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1041-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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