The Recall Desk
SevereFDA (Devices)·Z-0295-2016·Announced 2015-11-25

Fresenius 132 Gallon Dry Acid Dissolution Units Recalled for Fire Risk

Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.

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 in a medical device, which meets the rubric criteria for 'Severe' (score 4) due to the potential for significant injury or property damage.

Plain-English summary

Fresenius Medical Care Renal Therapies Group, LLC is recalling 348 units of the Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. These units are used in the preparation of acid concentrate for hemodialysis. The recall includes 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. Consumers and healthcare facilities should stop using the affected units immediately and contact the recalling firm for instructions on replacement or repair.

The recalled product

Product
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Hazard
Affected units
348

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 →