FDAClass IISeptember 2, 2015

Covidien Argyle Infant Heel Warmers recall

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

Why was Covidien Argyle Infant Heel Warmers recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X

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…
Recalling firm
Covidien LLC
Quantity
164, 749 units
Distribution
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Recall date
September 2, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls