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.
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, 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.
- 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.
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