NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks used in home dialysis systems because aluminum levels exceeded internal specifications.
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, and the hazard involves a deviation from internal specifications (excess aluminum) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
NxStage Medical, Inc. is recalling 8,683 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 to prepare dialysate for the NxStage System One. The specific reference number for the recalled product is SAK-307. The affected lots are 40179126, 40179125, 40179108, 40179036, 40179035, 31279119, 3057923, 3057907, and 3047927.
The product was distributed nationwide in the United States and internationally to France, the Netherlands, Spain, Sweden, and the United Kingdom. Patients and healthcare providers should check their inventory for these specific lot numbers and contact NxStage Medical for further instructions on how to proceed.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL…
- Manufacturer
- NxStage Medical, Inc.
- Affected units
- 8,683
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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Same hazard · aluminum exposure
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FDA (Devices) · 2014-07-02
- HighNxStage Dialysate Sacks Recalled for Excess Aluminum Levels
FDA (Devices) · 2014-07-02
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