Official recall record
Rotaflow Centrifugal Pump With Bioline
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-01-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
During retrospective internal testing, MCP/Getinge discovered narrow channels in the seal of the sterile bags used to package the RF-32. MCP/Getinge receives this sterile bag from a supplier that performs tests to verify sterility. Incomplete sealing can potentially lead to a breach of the sterile barrier. Recall start date: December 22, 2023
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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