Device Recall evaluemed Infant Heel Warmer 의 리콜

Recall

73281

Class 2

Z-1316-2016

2016-02-10

2016-04-04

Terminated

United States

2017-08-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143731

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.

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.