Fresenius AquaBplus Water Purification System Recalled for Installation Error
Fresenius Medical Care is recalling 27 AquaBplus water purification systems because an installation guideline error may reduce the effectiveness of heat disinfection.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential reduction in disinfection effectiveness due to an installation guideline error, with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 27 units of the AquaBplus and AquaBplus B2 Water Purification Systems. These devices are intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from water. The recall involves specific serial numbers for the AquaBplus, B2, and HF options, which were distributed nationwide in Florida, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, and Texas.
The recall was initiated due to an error in the US Installation Guideline for the AquaBplus HF module on the AquaBplus 2500 osmosis system. The guideline incorrectly instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with the device. This configuration, involving 3-ring mains and fluid fly loops, may result in heat disinfection that is not as effective as a 2-ring main installation.
Users of these systems should contact Fresenius Medical Care for further instructions regarding the installation correction. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3…
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 27
Distribution
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