• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device infusor, pressure, for i.v. bags
Regulation Description Pressure infusor for an I.V. bag.
Product CodeKZD
Regulation Number 880.5420
Device Class 1

Device Problems
Air Leak 35
Loss of or Failure to Bond 30
Leak/Splash 15
Device Contamination with Chemical or Other Material 12
Decrease in Pressure 10
Cuff 5
Crack 5
Missing Value Reason 4
Appropriate Term/Code Not Available 4
Device Operates Differently Than Expected 2
Insufficient Information 1
Bag 1
Device Issue 1
Inflation Problem 1
Pressure Problem 1
Device Operational Issue 1
Infusion or Flow Problem 1
Misassembly by Users 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 131

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jun-26-2017

-
-