FDA-Device2016-04-13Class II

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

Philips Electronics North America Corporation
Hazard

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.

Sold states
Nationwide distribution to Ohio only.
Affected count
539.156
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2016

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