Z-1041-2023 Class II Terminated
FDA device recall Z-1041-2023 was initiated by Carbon Medical Technologies, Inc. on December 16, 2022 and is designated Class II. 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… The recall status is terminated (terminated August 9, 2023). Affected quantity: 550 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- December 16, 2022
- Termination Date
- August 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 550 devices
Product Description
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
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 Pattern
US Nationwide distribution in the state of OHIO.
Code Information
UDI/DI 00858015005431, Lot Number 2201011A