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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device regulator, pressure, gas cylinder
Regulation Description Pressure regulator.
Product CodeCAN
Regulation Number 868.2700
Device Class 1


Premarket Reviews
ManufacturerDecision
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ERIE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FLOTEC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
MADA EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 3
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 4
Infusion or flow issue 3
Burst 3
Flare or flash 3
Inaccurate flowrate 2
Device inoperable 2
Device handling issue 2
Break 2
Detachment of device or device component 2
Improper flow or infusion 1
No Information 1
Incorrect display 1
Other (for use when an appropriate device code cannot be identified) 1
Component falling 1
Leak 1
Foreign material present in device 1
Misconnection 1
Medical Gas Supply problem 1
Spark 1
Increase in pressure 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
No flow 1
Total Device Problems 37

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

Recalls
Manufacturer Recall Class Date Posted
1 Airgas Puritan Medical II Oct-14-2009
2 Linde Gas North America Llc II Jun-20-2013
3 Praxair Inc. I Dec-21-2012
4 Precision Medical, Inc. II Nov-13-2015
5 Western - a Scott Fetzer Company II Oct-15-2009
6 Western / Scott Fetzer Company I Jul-20-2015
7 Western / Scott Fetzer Company II Jun-23-2014

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