Health product recall

Fresenius Blood Pump Rotor

Last updated

Summary

Product
Fresenius Blood Pump Rotor
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number/

Blood Pump Rotor (Spare Part) Used For Fresenius 2008T Hemodialysis System

Not applicable.

190729

Blood Pump Rotor (Spare Part) Used For K@Home

Not applicable.

191014
190395

Blood Pump Rotor (Spare Part) Used For 2008T Hemodialysis System CDX

Not applicable.

190713
190766
190908
190573

Issue

This is a field action notification by the manufacturer, Fresenius USA Inc. for Blood Pump Rotor Spare Parts that are compatible with 2008 series hemodialysis machine. The Blood Pump Rotor turns to move the blood along the blood pump segment of the machine. An increased number of complaints were reported to the manufacturer on the Blood Pump Rotor (p/n - f40015481 rev a, implemented in May 2020) after a period of use by clinics noting loose/dislodged guide sheaves. After thorough review of the complaints and root cause investigation, the manufacturer updated the Blood Pump Rotor design to p/n - f40015481 rev c to address customer complaints for bent guide pins due to improper unloading of blood lines.  The rev a part was installed as a component of the arterial blood pump on the 2008 series hemodialysis machines during the period May 2020 till Apr 2024. The blood pump rotor is also sold as a spare part for the 2008 series blood pump module. Since, rev c design is now complete, and the part is now available, Fresenius USA has initiated a field action notification to conduct medical device correction if necessary.

Recall start date: April 16, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Fresenius USA, Inc.

4040 Nelson Avenue, Concord, California, United States, 94520

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75480

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe