NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks used with the PureFlow SL system 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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
NxStage Medical, Inc. is recalling 5,488 cases of NxStage Dialysate Sacks (SAK) with Concentrate. These products are disposables 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-303.
The recall was initiated because the SAK Dialysate Concentrate contains aluminum levels that exceed the manufacturer's internal product specifications. The affected lot codes are 40179030, 3067904, 3067902, 3057925, 3057924, 3047934, and 3047929.
The affected products were distributed worldwide, including nationwide in the United States and internationally to France, the Netherlands, Spain, Sweden, and the United Kingdom. Users of the NxStage PureFlow SL system should check their inventory for the listed lot codes and contact NxStage Medical for further instructions.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 5,488
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 codes: 40179030 3067904 3067902 3057925 3057924 3047934 3047929
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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