Product Wiki · Recalls · Health Canada — Medical Devices

Maquet Percutaneous Insertion Kit and Dilator Sets — recall 82527

Health Canada — Medical Devices · Canada · 2026-08-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
82527
Date of alert
2026-08-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: The manufacturer became aware of this issue during retrospective review of historical packaging verification documentation. It was identified that there have been failures in sterile barrier integrity verification testing. As these failures were not previously addressed in accordance with packaging verification requirements, the packaging may not consistently maintain sterile barrier integrity. Therefore, this FSCA is limited to all products of the PIK line within shelf-life.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/maquet-percutaneous-insertion-

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