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 (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
NxStage Medical, Inc. is recalling 16,625 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 which exceed internal product specification.
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-304, with a batch size of 60 liters. The product was distributed nationwide in the USA and internationally to France, the Netherlands, Spain, Sweden, and the UK.
Patients and healthcare providers should stop using the affected SAKs and contact NxStage Medical for instructions on return or replacement. The recall covers specific lot codes including 40179091, 40179069, 40179068, 40179029, 40179019, 31279094, 3067901, 3057932, 3057919, 3057918, 3057909, and 3057908.
The recalled product
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialys
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 16,625
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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