FDA-Device2014-07-02Class II
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
NxStage Medical, Inc.
Hazard
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Affected count
91 cases
Manufactured in
350 Merrimack Street, N/A, Lawrence, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1861-2014Don't want to check this manually?
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