NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling 2,711 cases of dialysate sacks 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 3/5 (High).
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 (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
NxStage Medical, Inc. is recalling 2,711 cases of NxStage Dialysate Sacks (SAK) with Concentrate for use with the PureFlow SL system. The recall is being conducted because the SAK Dialysate Concentrate contains aluminum levels that exceed internal product specifications.
The affected product is a disposable bag pre-filled with dialysate concentrate, used to prepare dialysate for the NxStage System One. The specific reference number is SAK-306, with a batch size of 50 liters. The affected lot codes are 31279092, 3047917, and 3047916.
The product was distributed nationwide in the United States and internationally to France, the Netherlands, Spain, Sweden, and the United Kingdom. Users should stop using the affected lots and contact NxStage Medical for further instructions.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, 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
- 2,711
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: 31279092 3047917 3047916
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
See all →- SevereThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
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- SevereThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
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- SevereSmisson-Cartledge ThermaCor 1200 Disposable Sets Recalled for Aluminum Leaching Risk
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- HighNxStage Dialysate Sacks Recalled for Excess Aluminum Levels
FDA (Devices) · 2014-07-02
- ModerateNxStage Dialysate Sacks Recalled for Excess Aluminum Levels
FDA (Devices) · 2014-07-02
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