Public recall detail

Hollow Fiber Hemodialyzers

2025-09-16

medium
Recall Safety notice
Quick summary

Quick summary: Hollow Fiber Hemodialyzers. Date: 2025-09-16.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Hollow Fiber Hemodialyzers. Date: 2025-09-16.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandFresenius Medical Care North America
ProductHollow Fiber Hemodialyzers
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-78073

Affected products

ProductHollow Fiber Hemodialyzers
LotMore than 10 numbers, contact manufacturer.
Model0500316E
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHollow Fiber Hemodialyzers
ProductHollow Fiber Hemodialyzers
LotMore than 10 numbers, contact manufacturer.
Model0500320E
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHollow Fiber Hemodialyzers
ProductHollow Fiber Hemodialyzers
LotMore than 10 numbers, contact manufacturer.
Model0500325E
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHollow Fiber Hemodialyzers

Issue

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesFresenius Medical Care North America 920 Winter Street, Waltham, Massachusetts, United States, 02451
Recall date2025-09-08
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-78073
Background{}
CompaniesFresenius Medical Care North America 920 Winter Street, Waltham, Massachusetts, United States, 02451
AudiencesHealthcare
Source updated2025-09-16

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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