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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- 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.
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