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Hollow fiber hemodialyzers
Official notice
16 Sept 2025
Last checked
16 Sept 2025
An official Health Canada notice concerns Hollow fiber hemodialyzers. 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. Published 2025-09-16.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78073
Official notice
2025-09-16
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
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Phone
Brand: Fresenius Medical Care North, Hollow Fiber Hemodialyzers.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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