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Recall Observatory FDA recall evidence

Device product

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

Z-0543-2016

November 20, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 72681
Status
Terminated
Classification
Class II
Quantity
7,327,100 individual units
Official record key
device-enforcement:Z-0543-2016

Official wording

Reason: Heel warmers may cause first and second degree burns.

Code information: All product in distribution

Distribution pattern: Moberly, MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Heel warmers may cause first and second degree burns.