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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGCB
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 3
Break 2
Migration of device or device component 1
Air leak 1
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Device, removal of (non-implant) 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Sep-11-2013
2 Custom Healthcare Systems, Inc. II Jul-17-2015
3 Pfm Medical Inc II Dec-12-2014

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