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U.S. Department of Health and Human Services

Class 2 Device Recall MammoStar

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  Class 2 Device Recall MammoStar see related information
Date Initiated by Firm December 16, 2022
Date Posted January 30, 2023
Recall Status1 Terminated 3 on August 09, 2023
Recall Number Z-1041-2023
Recall Event ID 91419
510(K)Number K100994  
Product Classification Marker, radiographic, implantable - Product Code NEU
Product Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Code Information UDI/DI 00858015005431, Lot Number 2201011A
Recalling Firm/
Manufacturer		 Carbon Medical Technologies, Inc.
1290 Hammond Rd
Saint Paul MN 55110-5867
For Additional Information Contact Customer Support
888-207-2062
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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 info@carbonmed.com."
Quantity in Commerce 550 devices
Distribution US Nationwide distribution in the state of OHIO.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NEU and Original Applicant = CARBON MEDICAL TECHNOLOGIES, INC.
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