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U.S. Department of Health and Human Services

Class 2 Device Recall evaluemed Infant Heel Warmer

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  Class 2 Device Recall evaluemed Infant Heel Warmer see related information
Date Initiated by Firm February 10, 2016
Date Posted April 04, 2016
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-1316-2016
Recall Event ID 73281
510(K)Number K936084  
Product Classification Pack, hot or cold, disposable - Product Code IMD
Product evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim
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 2		 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.
510(K) Database 510(K)s with Product Code = IMD and Original Applicant = OMNI THERM, INC.
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