Reported Feb 4, 2015 · Terminated

Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85"…

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?

  • Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Lot codes and dates
  • Lot numbers
    • UR13125045
    • UR13126035
    • UR13126043
    • UR13K22031
    • UR131L06024
    • UR13L09077
    • UR13L10042
    • UR13L17047
    • UR14A17048
    • UR14A21057
    • UR14B05017
    • UR14B26039
    • UR14C06039
    • UR14C13068
    • UR14C27035
    • UR14D15046
    • and UR14E20043
Amount recalled
26,028 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

Potential for failure of the pouch packaging seal at high altitudes.

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 Apr 10, 2017 · Data as of Sep 19, 5:19 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.