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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, peritoneal
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBW
Regulation Number 878.4200
Device Class 1

Device Problems
Break 14
Detachment of Device or Device Component 5
Split 2
Material Separation 2
Catheter 2
Packaging Problem 1
Fluid Leak 1
Occlusion Within Device 1
Patient Device Interaction Problem 1
Physical Resistance/Sticking 1
Activation, Positioning or SeparationProblem 1
Decrease in Suction 1
Fracture 1
Difficult to Remove 1
Total Device Problems 34

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Mar-18-2018
2 ConMed Corporation II Oct-18-2016
3 Teleflex Medical II Nov-16-2015

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