Mammotome MammoStar Biopsy Site Identified recall
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Why was Mammotome MammoStar Biopsy Site Identified recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00858015005431, Lot Number 2201011A
- Product
- Mammotome MammoStar Biopsy Site Identified, REF STAR1401
- Recalling firm
- Carbon Medical Technologies, Inc.
- Quantity
- 550 devices
- Distribution
- US Nationwide distribution in the state of OHIO.
- Recall date
- February 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)