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THERASPHERE ADMINISTRATION SET (2021-07-23) — recall 62741

Health Canada — Medical Devices · Canada · 2021-08-06 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 62741
Date of alert: 2021-08-06
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: Boston Scientific is initiating a Product Advisory for specific lots of TheraSphereTM Administration Sets to reinforce the existing administration set assembly instructions within the instructions for use (IFU), which state to firmly connect the outlet luer to the patient catheter. This Product Advisory will also inform users of the potential for leaks at this connection.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/therasphere-administration-set

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

THERASPHERE ADMINISTRATION SET (2021-07-23) — recall 62741

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