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Official recall record

Perfusion Set With Bioline Coating

Health Canada — Medical Devices · 2024-12-06 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-12-06
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

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.

More recalls: Health Canada — Medical Devices · Canada · all filters

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