NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks used in dialysis systems because they contain aluminum levels exceeding internal specifications.
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 reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
NxStage Medical, Inc. is recalling 19,423 cases of NxStage Dialysate Sacks (SAK) with Concentrate for use with the PureFlow SL system. The recall was initiated because the SAK Dialysate Concentrate contains aluminum levels that exceed the company's internal product specifications.
The affected product is a disposable bag pre-filled with dialysate concentrate, which is used with the NxStage PureFlow SL Dialysate Preparation System to prepare dialysate for the NxStage System One. The specific reference number for the recalled product is SAK-302.
The recall covers distribution in the United States (nationwide) and internationally to France, the Netherlands, Spain, Sweden, and the UK. Consumers and healthcare providers should stop using the affected lots and contact NxStage Medical for instructions on return or replacement.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size (liters): 60 The SAK is one of the disposables used with NxStage PureFlow SL
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 19,423
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.
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