Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1855-2014 — 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 Preparatio

U.S. FDA — Device Enforcement · United States · 2014-05-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1855-2014
Date of alert: 2014-05-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: NxStage Medical, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 40179127

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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