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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drape, surgical
Regulation Description Surgical drape and drape accessories.
Product CodeKKX
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 7
A PLUS INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ADVANCED VASCULAR DYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
AUSTIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
BD
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 10
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CIVCO
  SUBSTANTIALLY EQUIVALENT 1
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 12
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
Eagle
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 1
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
JOYKEY INDUSTRIAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 8
LAC MAC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIKMARK, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 6
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 3
OR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
PROMEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
TAUT
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 3
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WELMED INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 6
Not Applicable 5
No Known Device Problem 5
No Information 4
Break 2
Tear, rip or hole in device packaging 2
Failure to Adhere or Bond 1
Energy output to patient tissue incorrect 1
Fire 1
Device, or device fragments remain in patient 1
Device operates differently than expected 1
Loss of or failure to bond 1
Unknown (for use when the device problem is not known) 1
Other (for use when an appropriate device code cannot be identified) 1
Burn of device or device component 1
Sticking 1
Foreign material present in device 1
Out-of-box failure 1
Device Issue 1
Total Device Problems 37

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

Recalls
Manufacturer Recall Class Date Posted
1 Blue Belt Technologies MN II Aug-21-2013
2 Custom Medical Specialties, Inc. II Feb-12-2014
3 Customed, Inc II Apr-14-2016
4 Customed, Inc II Sep-03-2015
5 Customed, Inc I Dec-16-2014
6 Customed, Inc I Aug-29-2014
7 Ecolab Inc II Feb-10-2014
8 Intuitive Surgical, Inc. II Apr-06-2015
9 Kimberly-Clark Corporation II Nov-07-2012
10 Kimberly-Clark Corporation III Sep-20-2012
11 Kimberly-Clark Corporation II Jul-21-2011
12 Microtek Medical, Inc. II Dec-10-2010
13 OEC Medical Systems, Inc II Jul-23-2008
14 Volcano Corporation II Mar-03-2016

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