Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2443-2015

July 31, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 71784
Status
Terminated
Classification
Class II
Quantity
68,800 units
Official record key
device-enforcement:Z-2443-2015

Official wording

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

Code information: Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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