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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

Device Problems
Break 9
Activation Failure Including Expansion Failures 4
Signal Artifact 3
Difficult to Remove 2
Device Operates Differently Than Expected 2
Insufficient Information 2
Device Markings / Labelling Problem 2
Difficult to Advance 2
Device Contamination with Chemical or Other Material 2
Plug 1
Detachment Of Device Component 1
Positioning Failure 1
Unsealed Device Packaging 1
Component Falling 1
Device Or Device Fragments Location Unknown 1
Detachment of Device or device Component 1
Suture 1
Tip 1
Total Device Problems 37

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II May-02-2017
2 Bard Peripheral Vascular Inc II Sep-16-2014
3 Hologic, Inc II Sep-08-2016
4 Stryker Instruments Div. of Stryker Corporation II Mar-03-2016

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