FDAFDA · Food and drugs·Recall number Z-1856-2014
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
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 codes: 40179030 3067904 3067902 3057925 3057924 3047934 3047929
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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