Z-2443-2015Class II

Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N

Name: Z-2443-2015 Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N
Creator: Covidien LLC
Published: 2015-07-31
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-07-31 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of 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... on 2015-07-31. FDA classified it as Class II and gives the reason as "Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2443-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Posted: 2015-08-21
Terminated: 2017-05-31
Recalling firm: Medtronic, Inc.
Product: 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
Product code: MPO Infant Heel Warmer (Chemical Heat Pack)
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
Root cause tag: packaging
FDA 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 in commerce: 68,800 units
Distribution: Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Product codes and lots: Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2443-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2443-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21
Z-2444-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code MPO

K964523Class IRecover Infant Heel Warmer (5100)Florida Medical Industries, Inc. / cleared 1997-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)