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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, noninvasive
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeGAZ
Regulation Number 880.6740
Device Class 2

Device Problems
Detachment of Device or device Component 13
Suction Failure 2
Material Integrity Problem 2
Detachment Of Device Component 2
Device Contamination with Chemical or Other Material 1
Human Factors Issue 1
Use of Device Problem 1
Material Twisted / Bent 1
Device Handling Problem 1
Decrease in Suction 1
Leak / Splash 1
Nonstandard device 1
Hole In Material 1
Adverse Event Without Identified Device or Use Problem 1
Collapse 1
Off-Label Use 1
Total Device Problems 31

Recalls
Manufacturer Recall Class Date Posted
1 ConMed Corporation II Oct-18-2016
2 Medtronic Minimally Invasive Therapies Group II Mar-05-2018

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