Recall Z-1041-2023 ยท NEU Marker, Radiographic, Implantable
Carbon Medical Technologies, Inc.
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
| Date | Jan 30, 2023 (initiated Dec 16, 2022) |
| Status | Terminated |
| 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 STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle. |
| Root cause | 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 |
| Quantity | 550 devices |
| Distribution | US Nationwide distribution in the state of OHIO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100994 | PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc., Apr 30, 2010 |