Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulatio…

Recall date
February 10, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1317-2016
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
Nationwide distribution to Ohio only.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

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