Dialysis water-treatment unit recalled for missing ferrite cores in cables
Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.
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: FDA Class II precautionary recall with no reported illnesses or injuries; electromagnetic compatibility non-compliance in a medical device where the actual risk to patient safety is theoretical and unconfirmed.
Plain-English summary
Fresenius Medical Care is recalling 6 units of the AquaC UNO H reverse osmosis unit (Fresenius Part Number 24-0970-1) intended for use with hemodialysis systems. The internal ethernet cables in these units are missing one or both ferrite cores, which prevents the device from meeting electromagnetic compatibility standards.
Electromagnetic compatibility standards ensure medical devices function correctly without interference from or to other equipment. No illnesses or injuries have been reported in connection with this recall.
The affected units were distributed nationwide to healthcare facilities in Arizona, California, the District of Columbia, Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania, and Texas. Healthcare facilities that have an affected unit should contact Fresenius Medical Care for replacement or remediation instructions.
The recalled product
- Product
- AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 6
Distribution
Part of a larger recall action
This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. 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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