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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical, needle
Regulation Description Manual surgical instrument for general use.
Product CodeFSH
Regulation Number 878.4800
Device Class 1

Device Problems
Structural Problem 1
Tear, Rip or Hole in Device Packaging 1
Component Misassembled 1
Total Device Problems 3

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Apr-18-2018

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