Fresenius Medical Care Holdings, Inc.: Device Recall

Recall Details

Recall Number

Z-2141-2024

Classification

Class II

Product Type

Device

Recalling Firm

Fresenius Medical Care Holdings, Inc.

Status

Ongoing

Date Initiated

05/16/2024

Location

Waltham, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

4 units

Reason for Recall

Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.

Product Description

US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1

Distribution Pattern

US Nationwide distribution in the states of AL, IN, AK, WI.

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. →