Mammotome MammoStar Biopsy Site Identified, REF STAR1401
This recall has been terminated (originally issued January 30, 2023).
- Recall Initiated
- December 16, 2022
- Posted
- January 30, 2023
- Terminated
- August 9, 2023
- Recall Number
- Z-1041-2023
- Quantity
- 550 devices
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI/DI 00858015005431, Lot Number 2201011A
Root 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."