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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device general surgery tray (kit)
Regulation Description Surgical drape and drape accessories.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeLRO
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 3
ALCON
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Leak 333
Device operates differently than expected 34
Dull 32
No Information 16
Foreign material present in device 14
No Known Device Problem 12
Fluid leak 11
Break 9
Detachment of device component 7
Air leak 5
Fitting problem 4
Sticking 4
Unknown (for use when the device problem is not known) 3
Detachment of device or device component 3
Bent 3
Difficult to insert 3
Dislodged or dislocated 3
Pressure issue 2
Material integrity issue 2
Device misassembled during manufacturing or shipping 2
Failure to advance 2
Component missing 2
Device inoperable 2
Difficult to remove 2
Material rigid or stiff 1
Slippage of device or device component 1
Improper or incorrect procedure or method 1
Obstruction within device 1
Cut in material 1
Physical resistance 1
Defective item 1
Aspiration issue 1
Difficult to open or close 1
Kinked 1
Loose or intermittent connection 1
Incorrect measurement 1
Device abrasion from instrument or another object 1
Nonstandard device or device component 1
Device, or device fragments remain in patient 1
Component falling 1
Degraded 1
Design/structure problem 1
Foreign material 1
Material fragmentation 1
Material frayed 1
Material twisted 1
Mechanical jam 1
Improper flow or infusion 1
Incorrect device or component shipped 1
Packaging issue 1
Positioning Issue 1
No code available 1
Noise, Audible 1
Total Device Problems 539

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 3 0 0
Class II 1 0 0 2 3 8 2 3 10 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd. II Oct-30-2015
2 Alcon Research, Ltd. II Jun-09-2015
3 Alcon Research, Ltd. II Jun-30-2014
4 Biomet 3i, LLC II Mar-12-2014
5 Cardinal Health II Feb-24-2012
6 Cardinal Health II Jan-27-2012
7 Cardinal Health II Jan-26-2012
8 Cardinal Health II Nov-07-2011
9 Cardinal Health II Oct-31-2011
10 Cardinal Health II Mar-16-2011
11 Centurion Medical Products Corporation II Jan-08-2015
12 Custom Medical Specialties, Inc. I Sep-20-2012
13 Customed, Inc II Apr-14-2016
14 Customed, Inc II Sep-03-2015
15 Customed, Inc I Dec-16-2014
16 Customed, Inc I Aug-29-2014
17 Customed, Inc II Mar-21-2012
18 DeRoyal Industries Inc II Dec-02-2015
19 DeRoyal Industries Inc II Nov-06-2015
20 DeRoyal Industries Inc II Jun-25-2015
21 DeRoyal Industries Inc II Jul-29-2014
22 DeRoyal Industries Inc II Jul-11-2013
23 DeRoyal Industries Inc II Jul-13-2012
24 DeRoyal Industries Inc II Mar-11-2010
25 Genzyme Corporation II Aug-28-2010
26 Gi Supply II Mar-04-2016
27 Medline Industries Inc II Dec-19-2012
28 Medline Industries Inc II Dec-17-2012
29 Medline Industries, Inc. I Feb-21-2014
30 Merit Medical Systems, Inc II Sep-25-2007
31 Merit Medical Systems, Inc. II Jul-03-2013
32 Merit Medical Systems, Inc. II Dec-03-2012
33 Resource Optimization & Innovation Llc II Nov-05-2015
34 Resource Optimization & Innovation Llc II Sep-21-2015
35 Stradis Healthcare, LLC. II Jul-07-2015

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