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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, i.v.
Regulation Description I.V. container.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
METRIX CO.
  SUBSTANTIALLY EQUIVALENT 2
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 351
Foreign material present in device 239
Hole in material 65
Disconnection 16
Particulates 13
Leak 10
Break 8
Suction issue 8
Detachment of device or device component 6
Crack 5
Material separation 5
Material rupture 4
Improper or incorrect procedure or method 4
Cut in material 4
Failure to disconnect 4
Connection issue 3
Device damaged prior to use 2
Bacterial contamination of device 2
Improper chemical reaction 2
Loose or intermittent connection 2
Contamination during use 2
Foreign material 1
Burst 1
Component(s), broken 1
Detachment of device component 1
Failure to prime 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Structural problem 1
Total Device Problems 763

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 3 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxa Corporation II Aug-02-2010
2 Baxa Corporation II Mar-09-2010
3 Baxter Healthcare Corp I Oct-31-2014
4 Baxter Healthcare Corp. II Apr-29-2010
5 Hospira Inc. II Sep-17-2012

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