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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device guide, needle, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeGDF
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 6
Failure to expand 4
Device or device fragments location unknown 3
Device operates differently than expected 2
Other (for use when an appropriate device code cannot be identified) 2
No Information 1
Detachment of device or device component 1
Detachment of device component 1
Component falling 1
Melted 1
Unsealed device packaging 1
Particulates 1
Device, or device fragments remain in patient 1
Material separation 1
Total Device Problems 26

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 1 0 0 2 0 0 1 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Sep-16-2014
2 Carefusion 2200 Inc II Jul-28-2010
3 Medical Device Technologies, Inc. II Jul-13-2010
4 Stryker Instruments Div. of Stryker Corporation II Mar-03-2016
5 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
6 Synovis Surgical Inovation Div. of II Jul-24-2007

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