Fresenius AquaBplus Water Purification Systems Recalled for Electrical Safety Defect
Fresenius Medical Care is recalling 15 AquaBplus water purification systems due to incorrectly crimped connectors that could cause electrical shock.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (electrical shock) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 15 units of the AquaBplus and AquaBplus B2 Water Purification Systems. These devices are used with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from water. The affected units were distributed to Delaware, North Carolina, Oklahoma, Pennsylvania, and Texas.
The recall was initiated because incorrectly crimped connectors were installed on the main protective earth conductor of the machines. If the equipment is moved or undergoes maintenance, these connections could become loose. This defect may adversely affect the electrical safety of the products, potentially resulting in electrical shock to biomedical technicians or clinic staff.
The source text does not specify instructions for consumers or healthcare facilities regarding the immediate handling of these units, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius…
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 15
Distribution
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