Carbon Medical Technologies, Inc. Recall 91419
Description: Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Carbon Medical Technologies, Inc. Recall 91419 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1041-2023 |
| Event ID | 91419 |
| Event Description | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of OHIO. |
| Quantity | 550 devices |
| Recall 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. |
| Device Classification | 20230208 |
| Device Code Info | UDI/DI 00858015005431, Lot Number 2201011A |
| Center Classification Date | 20230130 |
| Recall Initiation Date | 20221216 |
| Recalling Firm | Carbon Medical Technologies, Inc. |
| Initial Notification | |
| Similar To |