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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, piston
Regulation Description Piston syringe.
Product CodeFMF
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 7
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTSANA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
AVID MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 8
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
  1.  K021071  PCCS GRAFT DELIVERY SYSTEM
  2.  K072330  CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) A ...
  3.  K091722  COAXIAL APPLICATOR SYSTEM
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CONFLUENT SURGICAL,INC
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DMC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRAGON HEART MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND CO.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT - KIT 1
FEEL TECH
  SUBSTANTIALLY EQUIVALENT 1
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HARVEST
  SUBSTANTIALLY EQUIVALENT 2
HASELMEIER GMBH
  SUBSTANTIALLY EQUIVALENT 2
HENKE SASS WOLF
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
ISOTIS ORTHOBIOLOGICS, INC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SHENLI MEDICAL PRODUCTION FACTORY
  SUBSTANTIALLY EQUIVALENT 1
JMS
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 20
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEGEN
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 6
NISSHO CORP
  SUBSTANTIALLY EQUIVALENT 1
NOVO NORDISK
  SUBSTANTIALLY EQUIVALENT 3
OMRIX BIOPHARMACEUTICALS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 4
OSTEOBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD
  SUBSTANTIALLY EQUIVALENT 1
PALCO LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PINYONS MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAFETY 1ST
  SUBSTANTIALLY EQUIVALENT 1
SAFETY SYRINGES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIN CHANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 13
THE UNIVERSITY OF CHICAGO
  SUBSTANTIALLY EQUIVALENT 1
THERMOGENESIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TRIBOFILM RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ULTIMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VLV ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELMED INC.
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU WUZHOU GROUP CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Component(s), broken 140
Detachment of device component 67
Break 54
Shielding failure 31
Needle, separation 21
Syringe, defective 21
Failure to advance 10
Disassembly 10
Unknown (for use when the device problem is not known) 6
Detachment of device or device component 5
Use of Device Issue 5
Material puncture 4
Leak 4
Foreign material 4
Disconnection 3
Crack 3
No Information 3
Defective item 2
Other (for use when an appropriate device code cannot be identified) 2
Slippage of device or device component 2
No Known Device Problem 2
Failure to deploy 2
Measurement system incompatibility 1
Device Issue 1
Component incompatible 1
Air leak 1
Device, or device fragments remain in patient 1
Out-of-box failure 1
Device operates differently than expected 1
Material separation 1
Material Protrusion 1
Spillage, accidental 1
Moisture damage 1
Loose or intermittent connection 1
Device markings issue 1
Material rupture 1
Measurements, inaccurate 1
Difficult to insert 1
Calibration error 1
Packaging issue 1
Failure to deliver 1
Component missing 1
Filling problem 1
Fluid leak 1
Not Applicable 1
Tip breakage 1
Dislodged 1
Device inoperable 1
Device contamination with blood or blood product 1
Loose 1
Material deformation 1
Total Device Problems 430

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 1 0 0
Class II 4 5 8 4 1 3 0
Class III 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Bioscience II Nov-24-2007
2 Becton Dickinson & Company II Dec-19-2012
3 Becton Dickinson & Company II Dec-29-2009
4 Becton Dickinson & Company II Aug-12-2009
5 Becton Dickinson & Company II Jun-24-2009
6 Becton Dickinson & Company II Sep-18-2008
7 Becton Dickinson & Company II Apr-16-2008
8 Becton Dickinson & Company II May-24-2007
9 Becton Dickinson & Company II Apr-05-2007
10 Becton Dickinson & Company II Mar-03-2007
11 Biomet, Inc. III Jul-04-2007
12 Covidien LLC II May-31-2012
13 Ethicon, Inc. II Oct-22-2012
14 I-Flow Corporation II Sep-24-2009
15 Integra LifeSciences Corp. I Jun-22-2011
16 Integra Pain Management II Aug-14-2008
17 Merit Medical Systems, Inc. II Dec-02-2010
18 Merit Medical Systems, Inc. II Oct-15-2010
19 Merit Medical Systems, Inc. II Dec-14-2009
20 Merit Medical Systems, Inc. II Sep-21-2008
21 Nipro Medical Corporation II Mar-11-2010
22 Smith & Nephew Inc II Sep-20-2008
23 Synthes USA (HQ), Inc. II Sep-21-2011
24 Ulti Med, Inc. II Mar-31-2010
25 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Dec-28-2009
26 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Sep-24-2009
27 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Jun-24-2009

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