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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, suction, single patient use, portable, nonpowered
Regulation Description Nonpowered, single patient, portable suction apparatus.
Product CodeGCY
Regulation Number 878.4680
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERITAGE MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 6
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Air leak 146
Break 145
Other (for use when an appropriate device code cannot be identified) 103
Tears, rips, holes in device, device material 78
Locking mechanism failure 61
Valve(s), failure of 24
Unknown (for use when the device problem is not known) 12
Material perforation 10
Decrease in suction 5
Device, or device fragments remain in patient 5
Difficult to remove 5
Suction issue 4
Component(s), broken 3
Fracture 3
Device, removal of (non-implant) 3
Tip breakage 2
Device clogged 2
Implant, removal of 2
Fluid leak 2
Use of Device Issue 1
Defective item 1
Detachment of device or device component 1
No code available 1
Disassembly 1
Explanted 1
Disconnection 1
Occlusion within device 1
Replace 1
Circuit Failure 1
Material fragmentation 1
Patient-device incompatibility 1
Defective component 1
Blockage within device or device component 1
Detachment of device component 1
Dislodged 1
Elective removal 1
Inaccurate flowrate 1
Markings unclear 1
Product quality issue 1
Total Device Problems 635

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

Recalls
Manufacturer Recall Class Date Posted
1 Aspen Surgical Products, Inc. III May-22-2009
2 Genico, Inc., dba Genicon II Jul-02-2009
3 Integra LifeSciences Corp. II Sep-28-2010
4 MicroAire Surgical Instruments, LLC II Jun-09-2012
5 Terumo Cardiovascular Systems Corporation II Apr-15-2011
6 Zimmer Inc. II Sep-19-2008
7 Zimmer Inc. II Apr-09-2008

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