BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments
Brand(s)
Summary
Customer will be contacted with instructions to follow.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
BioPince™ Ultra Full Core Biopsy Instrument |
Contact the manufacturer. |
370-1580-02 |
BioPince™ Ultra Full Cpre Biopsy Instrument With Co-Axial Introducer Needle |
Contact the manufacturer. |
360-1080-03 |
Tru-Core™ II |
Contact the manufacturer. |
763116160X |
BioPince™ |
Contact the manufacturer. |
360-1580-01 |
Issue
A complaint was received regarding a small hole in the sterile barrier tray that is utilized for three products, BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments. Inspection of inventory identified the presence of the defect in ~0.29% of product manufactured in the period.
Recall start date: July 3, 2024
Additional information
Details
Argon Medical Devices Inc.
1445 Flat Creek Road, Athens, Texas, United States, 75751
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