Product Wiki · Recalls · Health Canada — Medical Devices

Perfusion Set With Bioline Coating — recall 76653

Health Canada — Medical Devices · Canada · 2024-12-06 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76653
Date of alert
2024-12-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/perfusion-set-bioline-coating

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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