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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, feeding
Regulation Description Gastrointestinal tube and accessories.
Product CodeFPD
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1
METRIX CO.
  SUBSTANTIALLY EQUIVALENT 1
MULTI-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVARTIS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ROSS PRODUCT DIV. ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 4
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1

Device Problems
Difficult to remove 10
Unknown (for use when the device problem is not known) 7
Material rigid or stiff 6
Detachment of device component 6
Leak 6
Kinked 5
Break 5
No Information 5
Incorrect device or component shipped 4
Occlusion within device 4
Defective item 4
Overdelivery 3
Tubing, incorrect placement of 3
Retraction problem 3
Hole in material 3
Migration of device or device component 3
Connection issue 3
Device markings issue 3
Dislodged or dislocated 3
Cut in material 3
Malposition of device 2
Device operates differently than expected 2
No Known Device Problem 2
Positioning Issue 2
Balloon leak(s) 2
Source, detachment from 2
Use of Device Issue 2
Defective component 2
Tube(s), defective 1
Insufficient flow or underinfusion 1
Obstruction within device 1
Balloon pinhole 1
Stretched 1
Tears, rips, holes in device, device material 1
Material separation 1
Size incorrect for patient 1
Difficult to position 1
Material puncture 1
Balloon rupture 1
Component(s), broken 1
Material disintegration 1
Incorrect display 1
Device expiration issue 1
Delivered as unsterile product 1
Loose or intermittent connection 1
Excess flow or overinfusion 1
Knotted 1
Scratched material 1
Device packaging compromised 1
Total Device Problems 126

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

Recalls
Manufacturer Recall Class Date Posted
1 Benlan, Inc. II Jan-06-2016
2 Nestle HealthCare Nutrition II Aug-06-2013

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