Z-2444-2015 Class II Terminated
FDA device recall Z-2444-2015 was initiated by Covidien LLC on Jul 31, 2015 and is designated Class II. 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 The recall status is terminated (terminated May 31, 2017). Affected quantity: 164, 749 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 2, 2015
- Initiation Date
- Jul 31, 2015
- Termination Date
- May 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164, 749 units
Product Description
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.
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
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Code Information
Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2444-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026