BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2444-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2444-2015
    Event ID
    71784
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    July 31, 2015
    Classification Date
    August 21, 2015
    Termination Date
    May 31, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    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.

    Reason

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

    Code Info

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

    Distribution

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

    Quantity

    164, 749 units