Covidien LLC recalls Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right a…

Recall date

July 31, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2443-2015

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling