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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saline, vascular access flush
Regulation Description Intravascular catheter.
Definition Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Product CodeNGT
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 4
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDEFILL, INC.
  SUBSTANTIALLY EQUIVALENT 4
NURSE ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Bacterial contamination of device 9
Device operates differently than expected 2
No Known Device Problem 2
Unknown (for use when the device problem is not known) 2
Nonstandard device or device component 1
Delivered as unsterile product 1
Total Device Problems 17

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 1 0 0
Class II 1 0 1 1 0 1 2 2 4 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Amsino Medical USA III Sep-15-2012
2 B. Braun Medical, Inc. II Sep-20-2007
3 Becton Dickinson & Company II Sep-22-2014
4 Centurion Medical Products Corporation II Sep-19-2014
5 Covidien LLC II Sep-01-2015
6 Covidien LLC II Sep-10-2013
7 Covidien LP II Dec-09-2010
8 Excelsior Medical Corp I Oct-20-2010
9 Excelsior Medical Corp II Feb-06-2009
10 Hospira Inc. II Jan-11-2012
11 MRP, LLC dba AMUSA II Aug-27-2015
12 MRP, LLC dba AMUSA II Jun-15-2015
13 MRP, LLC dba AMUSA II Jun-04-2015
14 Merit Medical Systems, Inc. I Feb-20-2014
15 Merit Medical Systems, Inc. II Jan-10-2013

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