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Recall Observatory FDA recall evidence

Device 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

Z-1316-2016

February 10, 2016

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 73281
Status
Terminated
Classification
Class II
Quantity
539.156
Official record key
device-enforcement:Z-1316-2016

Official wording

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.

Code information: All in distribution.

Distribution pattern: Nationwide distribution to Ohio only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.