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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
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
DEROYAL
  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 35
Dull 33
Foreign material present in device 16
No Information 16
No Known Device Problem 13
Break 13
Fluid leak 11
Detachment of device component 7
Air leak 5
Material integrity issue 5
Device misassembled during manufacturing or shipping 5
Sticking 4
Fitting problem 4
Unknown (for use when the device problem is not known) 4
Detachment of device or device component 3
Bent 3
Difficult to insert 3
Dislodged or dislocated 3
Packaging issue 2
Manufacturing or shipping issue associated with device 2
Pressure issue 2
Material fragmentation 2
Mechanical issue 2
Degraded 2
Component missing 2
Failure to advance 2
Misfire 2
Device inoperable 2
Difficult to remove 2
Material rigid or stiff 1
Slippage of device or device component 1
Loose or intermittent connection 1
Incorrect measurement 1
Improper or incorrect procedure or method 1
Material perforation 1
Physical resistance 1
Failure to cut 1
Defective item 1
Aspiration issue 1
Obstruction within device 1
Cut in material 1
Design/structure problem 1
Flaked 1
Foreign material 1
Component falling 1
Device abrasion from instrument or another object 1
Nonstandard device or device component 1
Device, or device fragments remain in patient 1
Material frayed 1
Hole in material 1
Kinked 1
No code available 1
Noise, Audible 1
Positioning Issue 1
Material twisted 1
Mechanical jam 1
Difficult to open or close 1
Improper flow or infusion 1
Incorrect device or component shipped 1
Item contaminated during manufacturing or shipping 1
Total Device Problems 569

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

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