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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nebulizer (direct patient interface)
Regulation Description Nebulizer.
Product CodeCAF
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
ACCESS POINT
  SUBSTANTIALLY EQUIVALENT 1
AEROGEN
  SUBSTANTIALLY EQUIVALENT 4
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 2
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
ARMSTRONG
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
CHOICE SMART HEALTH CARE CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
DHD HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
EMG
  SUBSTANTIALLY EQUIVALENT 2
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
GRAHAM-FIELD HEALTH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 2
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MABIS
  SUBSTANTIALLY EQUIVALENT 1
MADA EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 2
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
MED-EL
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 6
MERITS
  SUBSTANTIALLY EQUIVALENT 2
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
NEWPORT
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 7
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 9
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 7
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Infusion or flow issue 78
Leak 65
Connection issue 58
Tear, rip or hole in device packaging 46
No flow 36
Inaccurate delivery 31
Failure to deliver 29
Other (for use when an appropriate device code cannot be identified) 20
Device Issue 17
Improper flow or infusion 16
Device operates differently than expected 14
Decrease in pressure 14
Break 14
Peeled 13
Fitting problem 10
Loose or intermittent connection 10
Disconnection 10
Detachment of device component 9
Product quality issue 7
Overheating of device or device component 6
Detachment of device or device component 6
Crack 6
Electrical issue 6
Restricted flowrate 6
Therapeutic or diagnostic output failure 6
Air leak 5
Defective item 5
Unstable 5
Component missing 4
Component(s), broken 4
Noise, Audible 4
Temperature issue 4
Use of Device Issue 3
Device inoperable 3
Smoking 3
Sterility 3
Malfunction 3
Material separation 2
Noise 2
Hole in material 2
Occlusion within device 2
Kinked 2
Output, low 2
Device handling issue 2
Misassembled by Users 1
No Information 1
Pressure issue 1
Device emits odor 1
Mechanical issue 1
Delivered as unsterile product 1
Difficult to insert 1
Fire 1
Fluid leak 1
Material frayed 1
Insufficient heating 1
Adaptor, failure of 1
Degraded 1
Component(s), overheating of 1
Connection error 1
Couple, failure to 1
Device alarm system issue 1
Failure to Adhere or Bond 1
Blockage within device or device component 1
Burn of device or device component 1
Burst 1
Circuit Failure 1
Device Cleaning Issue 1
Valve(s), sticking 1
Device Rinsing Issue 1
Incomplete or missing packaging 1
Defective component 1
Seal, defective 1
Performance 1
Failure to power-up 1
Threader failure 1
Chemical issue 1
Disinfection or Sterilization Issue at User Location 1
Delivery system failure 1
Deployment issue 1
Device Contamination with biological material 1
Device markings issue 1
Filtration issue 1
Incorrect device or component shipped 1
Installation-related problem 1
Maintenance does not comply to manufacturers recommendations 1
Total Device Problems 634

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 1 1 0 2 3 4
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aerogen Ltd. II Oct-23-2014
2 Carefusion 211 Inc II Aug-12-2011
3 Compass Health Brands II Jun-06-2015
4 Nephron Pharmaceuticals Corp. II Jun-27-2016
5 Pharmacaribe llc II Feb-10-2016
6 Salter Labs II Feb-10-2016
7 Salter Labs II Sep-17-2015
8 Teleflex Creek Dr II Dec-28-2007
9 Teleflex Medical II Dec-12-2014
10 Thayer Medical Corporation II Jul-02-2012
11 Valeant Pharmaceuticals North America LLC II Dec-04-2015
12 Valeant Pharmacueticals International II Jan-21-2016

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