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Permanent life support and hls sets
Official notice
17 Jan 2023
Last checked
17 Jan 2023
An official Health Canada notice concerns Permanent life support and hls sets. Potentially compromised sterile barrier. The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed. Single sterilized and transport conditioned according to ASTM d4169-22 was conducted. However, the test samples were not double sterilized to cover an assumed worst condition of sterilization impact. These required tests are currently under way, however these test results will not be available until earliest in April 2023. Recall start date: January 9, 2023 Published 2023-01-17.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72591
Official notice
2023-01-17
The hazard
The hazard
Potentially compromised sterile barrier. The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed. Single sterilized and transport conditioned according to ASTM d4169-22 was conducted. However, the test samples were not double sterilized to cover an assumed worst condition of sterilization impact. These required tests are currently under way, however these test results will not be available until earliest in April 2023. Recall start date: January 9, 2023
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.
Recall Numbers
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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
Manufacturer
Phone
Brand: Maquet Cardiopulmonary, Permanent Life Support And Hls Sets.
Source & status
Source & status
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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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