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Recall Observatory FDA recall evidence

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

May 14, 2014

Class II

Product summary

Firm
NxStage Medical, Inc.
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

    reason.no_named_rule · v1.0.0

    SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification