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Dabir system

Official notice

14 Mar 2022

Last checked

14 Mar 2022

Medium riskHealth Canada

An official Health Canada notice concerns Dabir system. The device was incorrectly classified by manufacturer as a class I medical device and is in fact a class II medical device, which requires a medical device licence. Health Canada provided guidance on classification on December 24, 2021. Recall start date: Feb 14, 2022 and Mar 14, 2022 Published 2022-03-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63983

Official notice

2022-03-14

The hazard

The device was incorrectly classified by manufacturer as a class I medical device and is in fact a class II medical device, which requires a medical device licence. Health Canada provided guidance on classification on December 24, 2021. Recall start date: Feb 14, 2022 and Mar 14, 2022

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

63983

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Affected products

Product 1

Affected Products - Dabir Patient Care Plus System, Lot or Serial Number - 11210550002F, Model or catalog number - C2-10V1

Product 2

Affected Products - Dabir Patient Care Plus System, Lot or Serial Number - 11143530025F, 11150090006F, Model or catalog number - CA-1000

Risk / hazard

The device was incorrectly classified by manufacturer as a class I medical device and is in fact a class II medical device, which requires a medical device licence. Health Canada provided guidance on classification on December 24, 2021. Recall start date: Feb 14, 2022 and Mar 14, 2022

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

Manufacturer

Not provided

Phone

Not provided

Brand: Dabir Surfaces, Dabir System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63983

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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