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NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 1
Recalled July 2, 2014 · FDA recall Z-1861-2014 · NxStage Medical
Hazard
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification · FDA Class II
Units
91 cases
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Description
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →