PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 2, 2015 Initiated: July 31, 2015 #Z-2443-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Covidien LLC
Units Affected
68,800 units
Distribution
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Location
North Haven, CT

Frequently Asked Questions

What product 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. Recalled by Covidien LLC. Units affected: 68,800 units.
Why was this product recalled?
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
Which agency issued this recall?
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2443-2015.