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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, empty, for collection & processing of blood & blood components
Regulation Description Empty container for the collection and processing of blood and blood components.
Product CodeKSR
Regulation Number 864.9100
Device Class 2


Premarket Reviews
ManufacturerDecision
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 70
Fluid leak 24
Filter leak(s) 11
Break 7
Detachment of device component 4
Crack 4
Loose or intermittent connection 4
Hole in material 4
Foreign material present in device 3
Blockage within device or device component 3
Disconnection 2
Torn material 2
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Burst 1
Foreign material 1
Material rupture 1
Device damaged prior to use 1
Defective component 1
Component missing 1
Defective item 1
Device or device fragments location unknown 1
Total Device Problems 148

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Apr-12-2012

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