FDA-Device2015-09-02Class II
Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Covidien LLC
Hazard
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
Sold states
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Affected count
164, 749 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2444-2015Don't want to check this manually?
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