Fresenius Medical Care Holdings, Inc.: Device Recall

Recall Details

Recall Number

Z-3124-2024

Classification

Class II

Product Type

Device

Recalling Firm

Fresenius Medical Care Holdings, Inc.

Status

Ongoing

Date Initiated

08/08/2024

Location

Waltham, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

3,718 systems

Reason for Recall

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.

Product Description

Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130

Distribution Pattern

US Nationwide. Canada.

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. →