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

Recall Z-2443-2015 — Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling

U.S. FDA — Device Enforcement · United States · 2015-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2443-2015
Date of alert
2015-07-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LLC
Product category
device
Product type
Devices
Reported risk: Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
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.

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