Reported Mar 5, 2014 · Terminated

NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L…

NxStage Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NxStage Medical, Inc. · 350 Merrimack Street · Lawrence, MA · 01843-1748

Is this the product you have?

  • NxStage PureFlow-B Solution
  • Model/Catalog NumberRFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis
Lot codes and dates
  • Lot NumberF113662
Amount recalled
969 cases (2 bags per case)

Where it was sold

Why it was recalled

Mislabeled product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 29, 2014 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.