Fresenius Medical Care Holdings, Inc.: Device Recall

Recall #Z-1868-2024 · 04/17/2024

Class II: Risk

Recall Details

Recall Number: Z-1868-2024
Classification: Class II
Product Type: Device
Recalling Firm: Fresenius Medical Care Holdings, Inc.
Status: Ongoing
Date Initiated: 04/17/2024
Location: Waltham, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,292 units

Reason for Recall

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Product Description

2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Distribution Pattern

US Nationwide distribution.

Other Recalls by Fresenius Medical Care Holdings, Inc.

Class II: Risk 10/25/2025

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Class II: Risk 08/29/2025

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Class II: Risk 05/27/2025

Lack of Assurance of Sterility
Class II: Risk 04/29/2025

Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Class II: Risk 12/05/2024

Potential for internal blood leaks due to cracked polyurethane

View all recalls by Fresenius Medical Care Holdings, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.