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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device warmer, irrigation solution
Regulation Description Powered heating unit.
Product CodeLHC
Regulation Number 890.5950
Device Class 1


Premarket Reviews
ManufacturerDecision
ECOLAB INC.
  SUBSTANTIALLY EQUIVALENT 1
ECOLAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
GETINGE SOURCING, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Hole In Material 34
Material Puncture/Hole 9
Crack 4
Device Issue 2
Excessive Heating 1
Fluid Leak 1
Insufficient Information 1
Mechanical Problem 1
Improper or Incorrect Procedure or Method 1
Infusion or Flow Problem 1
Fracture 1
Leak/Splash 1
Device Inoperable 1
Sharp Edges 1
Inadequate or Insufficient Training 1
Strikethrough 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 62

Recalls
Manufacturer Recall Class Date Posted
1 Ecolab Inc II Sep-18-2015
2 Resource Optimization & Innovation Llc II Oct-30-2015
3 Smiths Medical ASD, Inc. II Jan-26-2017

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