BEUDAMED
    FDA Recall Terminated

    Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

    Recall: Z-0543-2016 · Initiated November 20, 2015

    Recall

    Recall Number
    Z-0543-2016
    Event Number
    72681
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    November 20, 2015
    Posted
    December 24, 2015
    Terminated
    August 7, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

    Reason

    Heel warmers may cause first and second degree burns.

    Action

    Cardial Health was notified of the recall via letter on 11/20/2015. Cardinal Health notified all of their customers as of 12/1/2015. Philips instructed Cardinal Health do take the following steps: 1.) Check for and destroy any inventory of Cardinal Health Tiny Toes. 2.) Complete the Distributor Reply Form included in this letter to document this action. Fax to Philips Healthcare at +1 404-855-4900. Please do not return any product to Philips. 3.) Determine which of your customers may have affected product. 4.) Ask your customers to follow the instructions in the section entitled: ACTIONS FOR CARDINAL HEALTH CUSTOMERS/USERS TO TAKE. 5.) As you receive signed Customer Reply Forms from your customers, please forward a running monthly summary to us. Please email the summary to Jennifer Maglio at [email protected]. To maintain complete documentation, please retain your customers completed reply forms. Philips may request access to particular reply forms to respond to an audit inquiry. Actions for Cardinal Health Customers to Take: 1.) Discontinue use of Cardinal Health Tiny Toes. 2.) Check for any inventory of Cardinal Health Tiny Toes. 3.) Destroy all products on hand (eg. by activating or puncturing each unit). 4.) Complete and sign the Customer Reply Form provided in this letter or Cardinal Healths version thereof, to notify Cardinal Health of how many Cardinal Health Tiny Toes were destroyed. Submit your signed reply form only after you have completed all steps

    Distribution

    Moberly, MO

    Quantity

    7,327,100 individual units