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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
Air leak 34
Fluid leak 26
Material separation 15
Disconnection 8
Failure to deliver 8
Leak 3
Particulates 2
Filter leak(s) 2
Crack 2
Overdelivery 1
Underdelivery 1
Inaccurate flowrate 1
Blockage within device or device component 1
Tubing, incorrect placement of 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 106

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