BEUDAMED
    FDA Recall Terminated

    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

    Recall: Z-1317-2016 · Initiated February 10, 2016

    Recall

    Recall Number
    Z-1317-2016
    Event Number
    73281
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 10, 2016
    Posted
    April 4, 2016
    Terminated
    August 1, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

    Reason

    eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

    Action

    Philips sent an Urgent Medical Device Recall leter dated January 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Actions for Tri-Anim Customers to Take 1.) Discontinue use of eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses. 2.) Check for any inventory of eValueMed Infant Heel Warmers or eValueMed Infant Transport Mattresses. 3.) Destroy all products on hand (e.g., by activating or puncturing each unit). Make a note of the total number of cases of products that were destroyed as this will be needed for step 4 below. 4.) Complete and sign the Customer Reply Form provided in this letter or Tri-anims version thereof, to notify Tri-anim of how many eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses were destroyed. Submit your signed reply form only after you have completed all steps. Please do not return any product to Philips. Customers with questions should call 336-449-5230 or 262-798-9802. For questions regarding this recall call 978-659-3000.

    Distribution

    Nationwide distribution to Ohio only.

    Quantity

    539.156