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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, coude
Regulation Description Urological catheter and accessories.
Product CodeEZC
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Deflation issue 4
No Information 3
Material rupture 2
Patient-device incompatibility 2
Mushroomed 1
No Known Device Problem 1
Torn material 1
Inaccurate flowrate 1
Leak 1
No device output 1
Material rigid or stiff 1
Insufficient flow or underinfusion 1
Component falling 1
Total Device Problems 20

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

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc., Urological Division II Sep-07-2012

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