Recall Z-1041-2023
Carbon Medical Technologies, Inc. · initiated December 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Codes / lots: UDI/DI 00858015005431, Lot Number 2201011A
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: Under Investigation by firm
Action taken
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."
Details
- Recall number
- Z-1041-2023
- Initiated
- December 16, 2022
- Posted by FDA
- January 30, 2023
- Terminated
- August 9, 2023
- Product code
- NEU – Marker, Radiographic, Implantable
- Quantity
- 550 devices
- Distribution
- US Nationwide distribution in the state of OHIO.
- Recalling firm
- Carbon Medical Technologies, Inc., Saint Paul, MN