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Recall Observatory FDA recall evidence

Device product

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, 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.

Z-1859-2014

May 14, 2014

Class II

Product summary

Firm
NxStage Medical, Inc.
Event
Event 68354
Status
Terminated
Classification
Class II
Quantity
2711 cases
Official record key
device-enforcement:Z-1859-2014

Official wording

Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Code information: Lot codes: 31279092 3047917 3047916

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