Z-0543-2016Class II

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

Name: Z-0543-2016 Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Creator: Philips Electronics North America Corporation
Published: 2015-11-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-11-20 / Terminated / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of Cardinal Health Tiny Toes; 11470-010T Infant heel warmer on 2015-11-20. FDA classified it as Class II and gives the reason as "Heel warmers may cause first and second degree burns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0543-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2015-12-24
Terminated: 2017-08-07
Recalling firm: Philips North America LLC
Product: Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: Heel warmers may cause first and second degree burns.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Cardial Health was notified of the recall via letter on 11/20/2015. Cardinal Health notified all of their customers as of 12/1/2015. Philips instructed Cardinal Health do take the following steps: 1.) Check for and destroy any inventory of Cardinal Health Tiny Toes. 2.) Complete the Distributor Reply Form included in this letter to document this action. Fax to Philips Healthcare at +1 404-855-4900. Please do not return any product to Philips. 3.) Determine which of your customers may have affected product. 4.) Ask your customers to follow the instructions in the section entitled: ACTIONS FOR CARDINAL HEALTH CUSTOMERS/USERS TO TAKE. 5.) As you receive signed Customer Reply Forms from your customers, please forward a running monthly summary to us. Please email the summary to Jennifer Maglio at [email protected]. To maintain complete documentation, please retain your customers completed reply forms. Philips may request access to particular reply forms to respond to an audit inquiry. Actions for Cardinal Health Customers to Take: 1.) Discontinue use of Cardinal Health Tiny Toes. 2.) Check for any inventory of Cardinal Health Tiny Toes. 3.) Destroy all products on hand (eg. by activating or puncturing each unit). 4.) Complete and sign the Customer Reply Form provided in this letter or Cardinal Healths version thereof, to notify Cardinal Health of how many Cardinal Health Tiny Toes were destroyed. Submit your signed reply form only after you have completed all steps
Quantity in commerce: 7,327,100 individual units
Distribution: Moberly, MO
Product codes and lots: All product in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0543-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0543-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

Product code IMD

K936084Class IOmni Warm Gel PacksOmni Therm, Inc. / cleared 1994-03-31

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)