Recall Z-1316-2016— Philips Electronics North America Corporation

Name: FDA recall Z-1316-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-10

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-02-10, terminated 2017-08-01. It names one FDA 510(k) clearance: K936084. 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. Reason: 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..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-02-10
Terminated: 2017-08-01
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K936084 — OMNI WARM GEL PACKSOmni Therm, Inc.·cleared 1994-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.