Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2015 - (Recall #: Z-0294-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.

Product Classification:

Class II

Date Initiated: October 23, 2015

Date Posted: November 25, 2015

Recall Number: Z-0294-2016

Event ID: 72484

Reason for Recall:

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

Status: Terminated

Product Quantity: 918 units

Code Information:

All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated