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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pack, hot or cold, reuseable
Regulation Description Cold pack.
Product CodeIME
Regulation Number 890.5700
Device Class 1


Premarket Reviews
ManufacturerDecision
HOSPITAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 8
Overheating of device or device component 4
Leak 4
Fire 3
Use of Device Issue 3
Temperature issue 2
Device handling issue 2
Spillage, accidental 1
Improper or incorrect procedure or method 1
Device operates differently than expected 1
Excessive cooling 1
Burn of device or device component 1
Loose 1
Total Device Problems 32

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Lansinoh Laboratories Inc II Feb-04-2013

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