Public recall detail

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

2024-08-19

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Recall Safety notice
Quick summary

Quick summary: BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments. Date: 2024-08-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments. Date: 2024-08-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandArgon Medical Devices Inc.
ProductBioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-75940

Affected products

ProductBioPince™ Ultra Full Core Biopsy Instrument
LotContact the manufacturer.
Model370-1580-02 360-1080-02 370-1080-02 360-1580-02 360-2080-02
Serial numberContact the manufacturer.
DescriptionBioPince™ Ultra Full Core Biopsy Instrument
ProductBioPince™ Ultra Full Cpre Biopsy Instrument With Co-Axial Introducer Needle
LotContact the manufacturer.
Model360-1080-03 360-2080-03 370-1580-03 360-1580-03 370-1080-03
Serial numberContact the manufacturer.
DescriptionBioPince™ Ultra Full Cpre Biopsy Instrument With Co-Axial Introducer Needle
ProductTru-Core™ II
LotContact the manufacturer.
Model763116160X 763120100X 763118100X 763418200X 763418250X 763114200X 763118200X 763114100X 763120160X 763116100X
Serial numberContact the manufacturer.
DescriptionTru-Core™ II
ProductBioPince™
LotContact the manufacturer.
Model360-1580-01 360-1080-01 370-1580-01 360-2080-01 370-1080-01
Serial numberContact the manufacturer.
DescriptionBioPince™

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

What you should do

  • Customer will be contacted with instructions to follow.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - General and plastic surgery
CompaniesArgon Medical Devices Inc. 1445 Flat Creek Road, Athens, Texas, United States, 75751
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75940
Background{}
CompaniesArgon Medical Devices Inc. 1445 Flat Creek Road, Athens, Texas, United States, 75751
AudiencesHealthcare
Source updated2024-08-19

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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