Fresenius Medical Care Holdings, Inc.: Device Recall

Recall #Z-0801-2025 · 12/05/2024

Class II: Risk

Recall Details

Recall Number: Z-0801-2025
Classification: Class II
Product Type: Device
Recalling Firm: Fresenius Medical Care Holdings, Inc.
Status: Ongoing
Date Initiated: 12/05/2024
Location: Waltham, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,351 cases (64,212 dialyzers)

Reason for Recall

Potential for internal blood leaks due to cracked polyurethane

Product Description

Dialyzer Optiflux 160NRe

Distribution Pattern

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 08/08/2024

Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

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.