Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Reported: February 8, 2023 Initiated: December 16, 2022 #Z-1041-2023
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.
Details
- Recalling Firm
- Carbon Medical Technologies, Inc.
- Units Affected
- 550 devices
- Distribution
- US Nationwide distribution in the state of OHIO.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Mammotome MammoStar Biopsy Site Identified, REF STAR1401. Recalled by Carbon Medical Technologies, Inc.. Units affected: 550 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Moderate. Recall number: Z-1041-2023.
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