Reported Jul 6, 2016 · Terminated

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Baxter Healthcare Corp.

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: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Lot codes and dates
    • Listing #D051124
    • Unique Device Identifier #07332414037048
    • Product code #105351
  • Lot code (Exp date)
    • 1000123133 (02/28/2017)
    • 1000128162 (04/30/2017)
    • 1000128163 (04/30/2017)
    • 1000128164 (04/30/2017)
Amount recalled
10,054 units

Where it was sold

Why it was recalled

Presence of leaks near top of the PrismaSate bags

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 Mar 28, 2017 · Data as of Sep 19, 6:02 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.