FDAFDA · Food and drugs·Recall number Z-1861-2014
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
Published July 2, 2014 · Recall initiated: May 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NxStage Medical, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
- Lot
- Lot code: 40179074
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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