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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, urological (antimicrobial) and accessories
Regulation Description Urological catheter and accessories.
Product CodeMJC
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Mushroomed 6
Restricted flowrate 3
Unsealed device packaging 3
Patient-device incompatibility 2
No Known Device Problem 2
No Information 1
Device operates differently than expected 1
Foreign material present in device 1
Improper flow or infusion 1
Kinked 1
Nonstandard device or device component 1
No flow 1
Total Device Problems 23

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

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Apr-08-2016
2 C.R. Bard, Inc. III Nov-02-2015

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