Health product recall

BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments

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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