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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, infusion line
Regulation Description Intravascular administration set.
Product CodeFPB
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 11
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDEX
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 108
Air leak 34
Crack 25
Leak 20
Material separation 15
Disconnection 11
Failure to deliver 10
Other (for use when an appropriate device code cannot be identified) 4
Break 3
Component(s), broken 2
Filter leak(s) 2
Unknown (for use when the device problem is not known) 2
Particulates 2
No flow 2
No code available 1
Overdelivery 1
Underdelivery 1
Device operates differently than expected 1
Material integrity issue 1
Reflux within device 1
Fracture 1
Tubing, incorrect placement of 1
Inaccurate flowrate 1
Bleed back 1
Blockage within device or device component 1
Total Device Problems 251

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

Recalls
Manufacturer Recall Class Date Posted
1 Pall Life Sciences Puerto Rico Llc II Jun-30-2011

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