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Health Canada Medical devices

Maquet Hemoconcentrator Set With Softline Coating

Issued December 18, 2024
Issue
An issue with eight technical drawings, specifically the absence of the bonding symbol for certain connections on the tubing set was found. It is important to note that the specified bonding procedure, which involved the use of cyclohexanone, was not carried out. While the absence of the bonding on the connectors may not be immediately apparent, it could potentially lead to leakage in the affected connections. Recall start date: December 9. 2024
Hazard description
Performance
Product
Product name
Hemoconcentrator Set With Softline Coating
Reference
ID
RA-76715