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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nebulizer, medicinal, non-ventilatory (atomizer)
Regulation Description Medicinal nonventilatory nebulizer (atomizer).
Product CodeCCQ
Regulation Number 868.5640
Device Class 1

Device Problems
Leak / Splash 41
Detachment Of Device Component 38
Break 27
No Flow 26
Detachment of Device or device Component 19
Failure to Deliver 17
Device Damaged Prior to Use 12
Restricted Flow rate 7
Connection Problem 5
Device Operates Differently Than Expected 4
Complete Blockage 2
Device Handling Problem 2
Disconnection 2
Obstruction of Flow 2
Inaccurate Delivery 1
Device Markings / Labelling Problem 1
Activation, Positioning or Separation Problem 1
Air Leak 1
Use of Device Problem 1
Moisture or Humidity Problem 1
Improper Flow or Infusion 1
Occlusion Within Device 1
Loss of or Failure to Bond 1
Total Device Problems 213

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Nov-09-2016

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