NxStage Dialysate Sack Recalled for Excess Aluminum Levels
NxStage Medical is recalling 91 cases of dialysate sacks because aluminum levels exceeded internal specifications. The product was distributed in the US and internationally.
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, injuries, or hospitalizations. The hazard is a deviation from internal specifications (aluminum levels) without explicit evidence of significant harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
NxStage Medical, Inc. is recalling 91 cases of NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL (REF: SAK-407). The specific lot code is 40179074. The product is a medical device used for dialysis.
The recall was initiated because the SAK Dialysate Concentrate contains aluminum levels which exceed internal product specifications. No specific health risks or reported illnesses are mentioned in the source text.
The affected product was distributed nationwide in the United States and internationally to France, the Netherlands, Spain, Sweden, and the United Kingdom. Users of this product should stop using the recalled lot and contact their healthcare provider or NxStage Medical for further instructions.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot code: 40179074
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by NxStage Medical, 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.
See all 8 products in this recall →Related recalls
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