FDAFDA · Food and drugs·Recall number Z-1041-2023
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Published February 8, 2023 · Recall initiated: December 16, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Carbon Medical Technologies, Inc.
- Distributor
- US Nationwide distribution in the state of OHIO.
- Lot
- UDI/DI 00858015005431, Lot Number 2201011A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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