Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1861-2014·Announced 2014-07-02

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.

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: 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.
Category: Medical Device — Dialysis Equipment
Hazard: aluminum-exposure
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 →

Same manufacturer · NxStage Medical, Inc.

See all →

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NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
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Same hazard · aluminum exposure