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Biopince™, biopince™ ultra and tru-core™ ii automatic biopsy instruments

Official notice

19 Aug 2024

Last checked

19 Aug 2024

Medium riskHealth Canada

An official Health Canada notice concerns Biopince™, biopince™ ultra and tru-core™ ii automatic biopsy instruments. 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 Published 2024-08-19.

What to do now

Customer will be contacted with instructions to follow.

Recall number

75940

Official notice

2024-08-19

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75940

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Affected products

Product 1

Affected products - BioPince™, Lot or serial number - Contact the manufacturer., Model or catalog number - 360-1580-01 360-1080-01 370-1580-01 360-2080-01 370-1080-01

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Argon Medical Devices, Biopince™ Biopince™ Ultra And Tru-core™ Ii Automatic Biopsy Instruments.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75940

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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