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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, irrigation, urological
Regulation Description Urological catheter and accessories.
Product CodeLJH
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NEXUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 16
Foreign material present in device 12
Disconnection 11
Device packaging compromised 4
Packaging issue 3
Detachment of device component 3
Device operates differently than expected 3
Fitting problem 2
Out-of-box failure 2
Hole in material 2
Slippage of device or device component 1
Suction issue 1
Component falling 1
Crack 1
Filling problem 1
Cut in material 1
Connection issue 1
Contamination of device ingredient or reagent 1
Break 1
Material integrity issue 1
No flow 1
Total Device Problems 69

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 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jul-10-2013
2 Hospira Inc. II May-16-2014
3 Stryker Endoscopy II Jul-19-2014

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