Fresenius GranuFlo Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to 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 from fire.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 918 units of the 132 Gallon GranuFlo Dissolution Unit (P/N G047-80101). These devices are used to prepare 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 is being issued 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 how to proceed.
The recalled product
- Product
- Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
- Affected units
- 918
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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Similar recalls
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