Product Wiki · Recalls · Health Canada — Medical Devices

Hollow Fiber Hemodialyzers — recall 78073

Health Canada — Medical Devices · Canada · 2025-09-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
78073
Date of alert
2025-09-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: The dialyzer caps had been changed from a threaded version to a push on version whereby the user must push the caps firmly onto the dialyzer to securely affix the cap. As users were accustomed to twisting the caps on, there were complaints of caps coming off resulting in dialysate leaks. two (2) of the complaints received in the United States reported a serious injury to the user related to a slip/fall resulting from the fluid leak. As part of CAPA actions by the manufacturer, IFU (F50010927 rev. B) was updated to IFU (F50010927 rev. C) to specify the method for securing the blood port cap to the dialysate port. As part of this recall, the updated IFU instructions will be communicated.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hollow-fiber-hemodialyzers

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