Product Wiki · Recalls · Health Canada — Medical Devices

Hls Set Advanced 5.0 and 7.0 With Bioline Coating — recall 64399

Health Canada — Medical Devices · Canada · 2022-07-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64399
Date of alert
2022-07-25
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: Maquet Cardiopulmonary Gmbh (MCP) has received customer complaints of damage to the primary packaging of the Hls Set Advanced. In all it was reported that the Tyvek cover was damaged. Investigation suggest that the Tyvek damage only occurs if the set drops upside down so either the velcro straps, holding the Hls modules, come loose or the Hls module detaches. A shift of the Hls module may cause the venous probe tab(s) to perforate the Tyvek cover. Possible sterility compromise. Recall start date: July 18, 2022.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hls-set-advanced-50-and-70-bio

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