Official recall record
Hemoconcentrator Set With Softline Coating
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-12-18
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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