Home / Recalls / Medical Devices
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 1
Recalled July 2, 2014 · FDA recall Z-1858-2014 · NxStage Medical
Hazard
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification · FDA Class II
Units
2839 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-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →