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Heater-cooler unit hcu 40
Official notice
6 Feb 2025
Last checked
6 Feb 2025
An official Health Canada notice concerns Heater-cooler unit hcu 40. The ice bracket is attached to the inlet of the cardioplegia tank where ice is produced. To avoid interrupting the water circulation on the cardioplegia side, ice must not cover the opening at the bottom of the tank. Due to its very high thermal conductivity, the ice bracket prevents ice buildup in the affected area and the opening always remains patent. An internal investigation came to the conclusion that the failure rate of the ice bracket becomes unacceptably high after two years. For devices where the ice bracket was replaced more than 2 years ago: The ice bracket shall be replaced as soon as possible free of charge. For devices where the ice bracket was replaced less than 2 years ago: The ice bracket shall be replaced during the next preventive maintenance free of charge. In the future (not part of this field action): The ice bracket will be replaced biennially during preventive maintenance. Recall start date: January 24, 2025 Published 2025-02-06.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76912
Official notice
2025-02-06
The hazard
The hazard
The ice bracket is attached to the inlet of the cardioplegia tank where ice is produced. To avoid interrupting the water circulation on the cardioplegia side, ice must not cover the opening at the bottom of the tank. Due to its very high thermal conductivity, the ice bracket prevents ice buildup in the affected area and the opening always remains patent. An internal investigation came to the conclusion that the failure rate of the ice bracket becomes unacceptably high after two years. For devices where the ice bracket was replaced more than 2 years ago: The ice bracket shall be replaced as soon as possible free of charge. For devices where the ice bracket was replaced less than 2 years ago: The ice bracket shall be replaced during the next preventive maintenance free of charge. In the future (not part of this field action): The ice bracket will be replaced biennially during preventive maintenance. Recall start date: January 24, 2025
How to check if you're affected
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.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Maquet Cardiopulmonary, Heater-cooler Unit Hcu 40.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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