Z-2443-2015 Class II Terminated
FDA device recall Z-2443-2015 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: 68,800 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
- 68,800 units
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
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Code Information
Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2443-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026