• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device apparatus, suction, operating-room, wall vacuum powered
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeGCX
Regulation Number 880.6740
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APLICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Suction issue 254
Vacuum, loss of 44
Foreign material present in device 19
Crack 12
Out-of-box failure 11
Disconnection 9
Fluid leak 6
Material separation 6
Device packaging compromised 6
Material fragmentation 4
Break 3
Leak 2
Hole in material 2
Use of Device Issue 2
Tip breakage 1
Device inoperable 1
Obstruction within device 1
Chemical spillage 1
Connection issue 1
Device operates differently than expected 1
Kinked 1
Reflux within device 1
Burst 1
Detachment of device component 1
Dislodged or dislocated 1
Tube(s), defective 1
Infusion or flow issue 1
Total Device Problems 393

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 0 0 0 0 0 0 2 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hospira Inc. II Aug-18-2016
2 Hospira Inc. II Dec-06-2013
3 Stryker Endoscopy II May-03-2013

-
-