The Recall Desk
SevereFDA (Devices)·Z-0296-2016·Announced 2015-11-25

Fresenius Modified Mixer Motor Recalled Due to Fire Risk

Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a fire hazard, which is a significant injury/property-damage risk, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Fresenius Medical Care Renal Therapies Group, LLC is recalling 992 units of the Modified Mixer Motor (P/N 160075) used in 132 Gallon Dissolution Units. These motors are used in the preparation of acid concentrate for hemodialysis. The recall covers all 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units equipped with the H218 Motor and Modified H218 Mixer Motors.

The recall was initiated because the dissolution units and replacement motor units do not provide full thermal protection for both the Main and Starter coils. This defect results in the generation of smoke and/or potentially leads to fire.

The affected products were distributed nationwide. Users should stop using the affected motors and contact the recalling firm for further instructions.

The recalled product

Product
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
Hazard
Affected units
992

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Fresenius Medical Care Renal Therapies Group, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →