BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments
Brand(s)
Last updated
Summary
Product
BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments
Issue
Medical devices - Labelling and packaging
What to do
Customer will be contacted with instructions to follow.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| BioPince™ Ultra Full Core Biopsy Instrument | Contact the manufacturer. | 370-1580-02 360-1080-02 370-1080-02 360-1580-02 360-2080-02 |
| BioPince™ Ultra Full Cpre Biopsy Instrument With Co-Axial Introducer Needle | Contact the manufacturer. | 360-1080-03 360-2080-03 370-1580-03 360-1580-03 370-1080-03 |
| Tru-Core™ II | Contact the manufacturer. | 763116160X 763120100X 763118100X 763418200X 763418250X 763114200X 763118200X 763114100X 763120160X 763116100X |
| BioPince™ | Contact the manufacturer. | 360-1580-01 360-1080-01 370-1580-01 360-2080-01 370-1080-01 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
Companies
Argon Medical Devices Inc.
1445 Flat Creek Road, Athens, Texas, United States, 75751
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75940
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