Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1317-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-02-10 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1317-2016
Date of alert
2016-02-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Electronics North America Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.