Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
METRIX CO.
  SUBSTANTIALLY EQUIVALENT 2
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 9
Suction issue 8
Particulates 3
Material separation 3
Material rupture 2
Contamination during use 1
Foreign material 1
Use of Device Issue 1
Component(s), broken 1
Unknown (for use when the device problem is not known) 1
Structural problem 1
Total Device Problems 31

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 3 0 1 0
Class III 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. II Apr-29-2010
4 Hospira Inc. II Sep-17-2012

-
-