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Perfusion set with bioline coating
Official notice
6 Dec 2024
Last checked
6 Dec 2024
An official Health Canada notice concerns Perfusion set with bioline coating. It was discovered that, in transitioning from versions 19 to 20 of the technical drawings, the PLEGIOX component was omitted on the drawing which, subsequently, resulted in the omission of the PLEGIOX IFU in the tubing pack. The affected lot numbers are missing the instructions for use for the PLEGIOX component in the tubing pack. Recall start date: December 2, 2024 Published 2024-12-06.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76653
Official notice
2024-12-06
The hazard
The hazard
It was discovered that, in transitioning from versions 19 to 20 of the technical drawings, the PLEGIOX component was omitted on the drawing which, subsequently, resulted in the omission of the PLEGIOX IFU in the tubing pack. The affected lot numbers are missing the instructions for use for the PLEGIOX component in the tubing pack. Recall start date: December 2, 2024
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
Lots
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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, Perfusion Set With Bioline Coating.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
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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