Device product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size (liters): 60 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.
Z-1855-2014
Product summary
- Event
- Event 68354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19423 cases
- Official record key
device-enforcement:Z-1855-2014
Official wording
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Code information: Lot codes: 40179127 40179107 40179109 40179105 40179093 40179034 31279120 31279118 3057921 3057920 3057915 3057914 3057906 3057905 3047924 3047923
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Derived failure modes
-
Unknown
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification