Recall Z-2444-2015 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
Covidien LLC
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.
| Date | Aug 21, 2015 (initiated Jul 31, 2015) |
| Status | Terminated |
| Reason | Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations |
| Root cause | Package design/selection |
| Action | Medtronic/Covidien issued an Urgent Medical Device recall letter dated July 31, 2015 via mailed Certified. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to quarantine and discontinue use of the affected products.. For questions or concerns,contact Medtronic representative or Customer Service at (800)-882-5878. |
| Quantity | 164, 749 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964523 | RECOVER INFANT HEEL WARMER (5100) Florida Medical Industries, Inc., Feb 10, 1997 |