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3-D matrix syringe adapter

Official notice

13 Jun 2023

Last checked

13 Jun 2023

Medium riskHealth Canada

An official Health Canada notice concerns 3-D matrix syringe adapter. The device 3-D Matrix Syringe Adapter does not meet the requirements of the medical device regulations. (Not licensed for use in Canada). There is no adapter defect. The 3-D Matrix Syringe Adapter it is an optional accessory for Purastat. Purastat is a licensed class IV device in Canada. Recall start date: May 17, 2023 Published 2023-06-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73808

Official notice

2023-06-13

The hazard

The device 3-D Matrix Syringe Adapter does not meet the requirements of the medical device regulations. (Not licensed for use in Canada). There is no adapter defect. The 3-D Matrix Syringe Adapter it is an optional accessory for Purastat. Purastat is a licensed class IV device in Canada. Recall start date: May 17, 2023

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

73808

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Affected products

Product 1

Affected products - 3-D Matrix Syringe Adapter, Lot or serial number - 21C30S 21C31S 17B13A 21C29S 20C19A 22C01S, Model or catalog number - 001-099 3DM-001-099

Risk / hazard

The device 3-D Matrix Syringe Adapter does not meet the requirements of the medical device regulations. (Not licensed for use in Canada). There is no adapter defect. The 3-D Matrix Syringe Adapter it is an optional accessory for Purastat. Purastat is a licensed class IV device in Canada. Recall start date: May 17, 2023

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: 3-d Matrix, 3-d Matrix Syringe Adapter.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73808

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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