Fresenius Bicarbonate Jug Adapter Recalled for Premature Distribution
Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.
What this means for you
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, but the source text does not report any illnesses or injuries, and the hazard is primarily regulatory (distribution prior to approval), fitting the criteria for a moderate severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 703 units of the Bicarbonate Jug Adapter (Part Number 650103) for the 2008 Series Hemodialysis machine. The adapter is a socket that accepts the machine spike to draw concentrate from the container. The recall was initiated because the product was distributed prior to receiving FDA 510(k) approval.
The affected units were distributed nationwide. No specific illnesses, injuries, or adverse events are reported in the source text. Consumers and healthcare facilities should stop using the affected adapters and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 703
Distribution
Distributed nationwide across the United States.
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