Recall Z-0543-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0543-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-20

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-11-20, terminated 2017-08-07. It names one FDA 510(k) clearance: K936084. Product: Cardinal Health Tiny Toes; 11470-010T Infant heel warmer. Reason: Heel warmers may cause first and second degree burns..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Terminated: 2017-08-07
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

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

Reason for recall

Heel warmers may cause first and second degree burns.

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