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Microtek decanter devices

Official notice

14 Jun 2024

Last checked

14 Jun 2024

Medium riskHealth Canada

An official Health Canada notice concerns Microtek decanter devices. During sterile barrier testing performed on the decanter product line the samples were identified to have pin holes and tears in the packaging film. Furthermore, the specified decanter devices were not licensed in accordance with Canadian Medical Devices Regulations. Recall start date: May 24, 2024 Published 2024-06-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75665

Official notice

2024-06-14

The hazard

During sterile barrier testing performed on the decanter product line the samples were identified to have pin holes and tears in the packaging film. Furthermore, the specified decanter devices were not licensed in accordance with Canadian Medical Devices Regulations. Recall start date: May 24, 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

75665

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Affected products

Product 1

Affected products - Transfer Device, Lot or serial number - 170828 231027, Model or catalog number - 2008S

Product 2

Affected products - Vial Decanter, Lot or serial number - 231230 180620, Model or catalog number - 2006S

Product 3

Affected products - Bottle Decanter, Lot or serial number - 180625 221220, Model or catalog number - 2004S

Product 4

Affected products - C-Flo Bag Decanter, Lot or serial number - 180122 240110, Model or catalog number - 2000S

Product 5

Affected products - Bag Decanter II, Lot or serial number - 240219 170216, Model or catalog number - 2002S

Risk / hazard

During sterile barrier testing performed on the decanter product line the samples were identified to have pin holes and tears in the packaging film. Furthermore, the specified decanter devices were not licensed in accordance with Canadian Medical Devices Regulations. Recall start date: May 24, 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

Manufacturer

Not provided

Phone

Not provided

Brand: Microtek Medical [an Ecolab Company], Microtek Decanter Devices.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75665

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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