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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
Device Handling Problem 2
Obstruction of Flow 2
Complete Blockage 2
Disconnection 2
Occlusion Within Device 1
Use of Device Problem 1
Air Leak 1
Loss of or Failure to Bond 1
Activation, Positioning or SeparationProblem 1
Device Markings/Labelling Problem 1
Inaccurate Delivery 1
Improper Flow or Infusion 1
Moisture or Humidity Problem 1
Total Device Problems 213

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

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