Reported Sep 2, 2015 · Terminated

Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right…

Covidien LLC

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: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Covidien Argyle Infant
  • Heel Warmers (with tab) Item CodeMH00002T
  • Product UsageIntended for application of the right amount of heat to an infants heel for blood sampling
Lot codes and dates
  • Lot Codes
    • 309907X
    • 310604X
    • 310704X
    • 312110X
    • 312329X
    • 313034X
    • 313615X
    • 314212X
    • 314308X
    • 317921X
    • 318904X
    • 320714X
    • 320715X
    • 321312X
    • 321423X
    • 321712X
    • 321812X
    • 321826X
    • 321903X
    • 322120X
Amount recalled
164, 749 units

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

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 May 31, 2017 · Data as of Sep 19, 6:06 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.