Z-1316-2016Class II

evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when...

Name: Z-1316-2016 evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when...
Creator: Philips Electronics North America Corporation
Published: 2016-02-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-02-10 / Terminated / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in... on 2016-02-10. FDA classified it as Class II and gives the reason as "eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification". 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-1316-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-10
Posted: 2016-04-04
Terminated: 2017-08-01
Recalling firm: Philips North America LLC
Product: evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Philips sent an Urgent Medical Device Recall leter dated January 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Actions for Tri-Anim Customers to Take 1.) Discontinue use of eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses. 2.) Check for any inventory of eValueMed Infant Heel Warmers or eValueMed Infant Transport Mattresses. 3.) Destroy all products on hand (e.g., by activating or puncturing each unit). Make a note of the total number of cases of products that were destroyed as this will be needed for step 4 below. 4.) Complete and sign the Customer Reply Form provided in this letter or Tri-anims version thereof, to notify Tri-anim of how many eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses were destroyed. Submit your signed reply form only after you have completed all steps. Please do not return any product to Philips. Customers with questions should call 336-449-5230 or 262-798-9802. For questions regarding this recall call 978-659-3000.
Quantity in commerce: 539.156
Distribution: Nationwide distribution to Ohio only.
Product codes and lots: All in distribution.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-04
Z-1317-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-04

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)