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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
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 10
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
  1.  K801082  GAMBRO HEMOFREEZE-BAG
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 23
ORIGEN BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 70
Fluid leak 24
Filter leak(s) 11
Break 7
Crack 6
Detachment of device component 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
Component missing 2
Manufacturing or shipping issue associated with device 2
Torn material 2
No Information 1
Material deformation 1
Material integrity issue 1
Scratched material 1
Defective item 1
Device or device fragments location unknown 1
Foreign material 1
Material rupture 1
Use of Device Issue 1
Device damaged prior to use 1
Defective component 1
Failure to Adhere or Bond 1
Burst 1
Total Device Problems 157

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