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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, specimen, sterile
Regulation Description Specimen transport and storage container.
Product CodeFMH
Regulation Number 864.3250
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material rupture 12
Fluid leak 9
Material separation 7
Material fragmentation 6
Leak 6
Device operates differently than expected 3
No code available 3
Defective item 2
Burst 2
Break 1
Unraveled material 1
Failure to disconnect 1
Deployment issue 1
Detachment of device or device component 1
Difficult to open or close 1
Dislodged or dislocated 1
Material integrity issue 1
Total Device Problems 58

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 2 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company III Apr-04-2013
2 Customed, Inc II Sep-03-2015
3 Customed, Inc I Dec-16-2014
4 Customed, Inc I Aug-29-2014

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