—#139096

Product

Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.

FDA product code: MPO — Infant Heel Warmer (Chemical Heat Pack)
Device class: Class 1
Medical specialty: Physical Medicine
510(k) numbers: K964523
Affected lot / code info: Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X

Why it was recalled

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

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

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

Timeline

Recall initiated: 2015-07-31
Posted by FDA: 2015-08-21
Terminated: 2017-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.