Class 2 Device Recall eValueMed Infant Transport Mattress

• Date Initiated by Firm: February 10, 2016
• Date Posted: April 04, 2016
• Recall Status: Terminated on August 01, 2017
• Recall Number: Z-1317-2016
• Recall Event ID: 73281
• Product Classification: Pack, hot or cold, disposable - Product Code IMD
• Product: 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
• Code Information: All in distribution.
• Recalling Firm/ Manufacturer: Philips Electronics North America Corporation; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 978-659-3000
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling design
• 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.
• Quantity in Commerce: 539.156
• Distribution: Nationwide distribution to Ohio only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.