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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heparin, 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 CodeNZW
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
MEDEFILL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 258
Contamination of device ingredient or reagent 65
Unknown (for use when the device problem is not known) 16
Bacterial contamination of device 10
No Information 6
No Known Device Problem 2
Contamination during use 2
Reaction 1
Device ingredient or reagent issue 1
Patient-device incompatibility 1
Total Device Problems 362

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 3 0 1 0 3 0 0 1 1
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 App Pharmaceuticals Llc II Jun-19-2012
2 Baxter Healthcare Corp. II Apr-04-2008
3 Covidien LP II May-09-2008
4 Excelsior Medical Corp II Jun-14-2016
5 Excelsior Medical Corp II Jun-05-2012
6 Fresenius Kabi USA, LLC II Jan-29-2015
7 Medefil Incorporated III Mar-06-2014
8 Medefil Incorporated II Dec-10-2010
9 Medefil Incorporated II May-09-2008
10 Vygon Corporation II Jun-13-2012

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