• 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 bottle, collection, vacuum
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeKDQ
Regulation Number 880.6740
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 8
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Vacuum, loss of 94
Suction issue 22
Material separation 18
Break 16
Leak 12
Other (for use when an appropriate device code cannot be identified) 12
Air leak 9
Component(s), broken 7
Device operates differently than expected 7
Crack 5
Fluid leak 4
No Known Device Problem 4
No code available 4
Material integrity issue 3
Connection issue 3
Device, or device fragments remain in patient 3
Difficult to remove 3
Disconnection 3
Contamination during use 3
Material disintegration 2
Device Issue 2
Malfunction 2
Detachment of device or device component 2
Failure to auto stop 2
Use of Device Issue 2
Protective measure issue 1
Incompatibility problem 1
Difficult to advance 1
Dislodged or dislocated 1
Tube(s), defective 1
Bacterial contamination of device 1
Split 1
Locking mechanism failure 1
Malposition of device 1
Fracture 1
Fitting problem 1
Replace 1
Retraction problem 1
Material rupture 1
Shelf life exceeded 1
Syringe, defective 1
Tubing, incorrect placement of 1
Decrease in suction 1
Design/structure problem 1
Loose or intermittent connection 1
Method, improper/incorrect 1
Migration of device or device component 1
Occlusion within device 1
Couple, failure to 1
Detachment of device component 1
Absorption 1
Burst 1
Device clogged 1
Total Device Problems 272

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

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Aug-20-2013
2 DeRoyal Industries Inc II Oct-20-2014
3 DeRoyal Industries Inc II Oct-20-2010
4 Hologic, Inc II Jul-19-2016
5 Ohio Medical Corporation II Oct-29-2009
6 Stryker Sustainability Solutions I Jan-04-2016
7 Teleflex Medical II Apr-08-2015

-
-