CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
Argyle Infant Heel Warmers (with tab) recalled by Covidien
Covidien is recalling Argyle Infant Heel Warmers (with tab), distributed nationwide in the US. The recall was initiated on 31 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2444-2015
- FDA event ID
- 71784
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2015
- FDA classified
- 21 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 31 Jul 2015 | Recall initiated by company | |
| 21 Aug 2015 | Classified by FDA | +21 days |
| 2 Sep 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Questions about this recall
Why was it recalled?
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
Which lots are affected?
Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X
Where was it sold?
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71784| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Argyle Infant Heel Warmers (no tab) recalled by Covidien | Covidien | Device Malfunction | Nationwide |
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