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Terminated

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

FDA Recall Z-2443-2015 · Posted 2015-08-21

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeMPO
Date Initiated2015-07-31
Date Terminated2017-05-31
Product Quantity68,800 units

Reason for Recall

Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

Firm Action

Medtronic/Covidien issued an Urgent Medical Device recall letter dated July 31, 2015 via mailed Certified. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to quarantine and discontinue use of the affected products.. For questions or concerns,contact Medtronic representative or Customer Service at (800)-882-5878.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964523RECOVER INFANT HEEL WARMER (5100)Florida Medical Industries, Inc. · 1997-02-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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