Device 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
Z-1858-2014
Product summary
- Event
- Event 68354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2839 cases
- Official record key
device-enforcement:Z-1858-2014
Official wording
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Code information: Lot codes: 40179026 3057901 3047930
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