BioPince, BioPince Ultra, and Tru-Core II recall in Canada: packaging defect
In plain language
This recall involves BioPince, BioPince Ultra, and Tru-Core II automatic biopsy instruments sold in Canada. They are being recalled because a small hole was found in the sterile packaging. Healthcare professionals should stop using the affected products and follow the instructions from the manufacturer.
What to do
- Stop using the product immediately.
- Contact Argon Medical Devices Inc. for instructions.
- Check model numbers if provided.
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Affected products
BioPince™ Ultra Full Core Biopsy Instrument
Model: 360-1080-02, 360-1580-02, 360-2080-02, 370-1080-02, 370-1580-02
Lot: Contact the manufacturer.
BioPince™ Ultra Full Cpre Biopsy Instrument With Co-Axial Introducer Needle
Model: 360-1080-03, 360-1580-03, 360-2080-03, 370-1080-03, 370-1580-03
Lot: Contact the manufacturer.
Tru-Core™ II
Model: 763114100X, 763114200X, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X
Lot: Contact the manufacturer.
BioPince™
Model: 360-1080-01, 360-1580-01, 360-2080-01, 370-1080-01, 370-1580-01
Lot: Contact the manufacturer.
Why this matters
Compromised sterility due to packaging defect
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: Contact the manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03, 763114100X, 763114200X, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Compromised sterility due to packaging defect
What should consumers do?
Stop using the product immediately. Contact Argon Medical Devices Inc. for instructions. Check model numbers if provided.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Compromised sterility due to packaging defect
When was this product recalled?
This product was recalled on August 19, 2024.
Is the BioPince, BioPince Ultra, Tru-Core II brand affected by this recall?
Yes, BioPince, BioPince Ultra, Tru-Core II products are affected by this recall. This recall involves BioPince, BioPince Ultra, and Tru-Core II automatic biopsy instruments sold in Canada. They are being recalled because a small hole was found in the sterile packaging. Healthcare professionals should stop using the affected products and follow the instructions from the manufacturer.