NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (dialysate) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
NxStage Medical, Inc. is recalling 2,839 cases of NxStage Dialysate Sacks (SAK) with Concentrate for use with PureFlow SL. The specific reference number is SAK-305, with a batch size of 40 liters. The affected lot codes are 40179026, 3057901, and 3047930.
The recall was initiated because the SAK Dialysate Concentrate contains aluminum levels that exceed the manufacturer's internal product specifications. The FDA has classified this as a Class II recall.
The affected products were distributed nationwide in the United States and internationally to France, the Netherlands, Spain, Sweden, and the United Kingdom. Users of these dialysate sacks should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 2,839
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: 40179026 3057901 3047930
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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