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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, non-rigid
Regulation Description Flexible laryngoscope.
Product CodeCAL
Regulation Number 868.5530
Device Class 1

Device Problems
Device Reprocessing Problem 4
Metal Shedding Debris 3
Microbial Contamination of Device 2
Flaked 2
Positioning Failure 1
Display or Visual Feedback Problem 1
Material Fragmentation 1
Delamination 1
Poor Quality Image 1
Detachment Of Device Component 1
Battery Problem 1
Total Device Problems 18

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company II Jun-28-2016

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