Product Wiki · Recalls · Health Canada — Medical Devices

HLS Set Advanced 5.0/7.0 with BIOLINE Coating (2020-11-10) — recall 61846

Health Canada — Medical Devices · Canada · 2020-11-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61846
Date of alert
2020-11-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: During verification testing and a review of customer complaints for the HLS Set Maquet Cardiopulmonary (MCP) identified a potential impairment of the sterile packaging barrier. Under the transport simulation verification tests, movements of the device and its accessories inside the plastic tray have been identified. As a result the sterile barrier for the system may be compromised.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hls-set-advanced-5070-bioline-

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