Reported May 15, 2013 · Terminated

A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male…

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?

  • A) Product Code 2N8371
    • Non-DEHP Y-Type Catheter Extension Set Kit
    • 6.0"
    • Vol. 1.0 mL
    • 2 Luer Activated Valves
    • Male Luer Lock Adapter
  • Single use only Product UsageThe IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids
Lot codes and dates
  • A) Product Code 2N8371
    • Lots R12E03108
    • R12H27085
    • R12H28075
    • R12H29057
    • R12H30139
    • R12103092
    • R12104058
    • R12105022
    • R12106061
    • R12110113
    • R12119056
    • R12120112
    • R12121151
    • R12122050
    • R12124106
    • R12124130
    • R12J25045
    • R12K03057
    • R12K19046
    • R12K21034
    • R12K21083
    • R12L05118
    • R12L08054
    • R12L18111
    • R12Ll9101
    • R13A08063
    • R13A08147
    • Rl3A09137
    • R13A10101
    • R13A14129
    • R13A15050
Amount recalled
A) Product Code 2N8371: 513,000 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

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 Jul 31, 2017 · Data as of Sep 19, 4:51 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.