Device product
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.
Z-2444-2015
Product summary
- Firm
- Covidien LLC
- Event
- Event 71784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 164, 749 units
- Official record key
device-enforcement:Z-2444-2015
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: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X
Distribution pattern: Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Derived failure modes
-
Unknown
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations