Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2019 - (Recall #: Z-1699-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Product Classification:

Class III

Date Initiated: April 3, 2019
Date Posted: June 12, 2019
Recall Number: Z-1699-2019
Event ID: 82729
Reason for Recall:

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Status: Terminated
Product Quantity: 257 units
Code Information:

Software v.2.72

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated