TPLC - Total Product Life Cycle

• Device: tubes, vials, systems, serum separators, blood collection
• Regulation Description: Blood specimen collection device.
• Product Code: JKA
• Regulation Number: 862.1675
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BD
	SUBSTANTIALLY EQUIVALENT	18
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
BMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EPITOME
	SUBSTANTIALLY EQUIVALENT	2
GREINER BIO-ONE
	SUBSTANTIALLY EQUIVALENT	4
HOME ACCESS
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
ICU MEDICAL SALES, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL TECHNIDYNE CORP.
	SUBSTANTIALLY EQUIVALENT	3
KENDALL
	SUBSTANTIALLY EQUIVALENT	9
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ORASURE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
PORTEX, INC.
	SUBSTANTIALLY EQUIVALENT	3
QUEST MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RADIOMETER
	SUBSTANTIALLY EQUIVALENT	1
SIMS
	SUBSTANTIALLY EQUIVALENT	1
SMITHS
	SUBSTANTIALLY EQUIVALENT	5
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Air leak	35
Detachment of device component	18
Component(s), broken	11
Needle, unsheathed	10
Disengaged	5
Needle, separation	4
Leak	3
Improper or incorrect procedure or method	3
Shielding failure	3
Retraction problem	2
Break	2
Failure to capture	2
Use of Device Issue	2
Detachment of device or device component	2
Fluid leak	1
Misapplication	1
Unknown (for use when the device problem is not known)	1
Defective item	1
Spillage, accidental	1
Sticking	1
Inadequate training	1
Total Device Problems	109

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	3	1	2	3	3	0
Class III	0	1	0	1	1	0	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	III	Mar-06-2013
2	Becton Dickinson & Company	III	Nov-08-2011
3	Becton Dickinson & Company	II	Jan-23-2008
4	Becton Dickinson & Company	II	May-10-2007
5	Capitol Vial Inc	II	Feb-24-2012
6	Celsus Laboratories Inc	II	Jul-18-2008
7	Covidien LP	II	Mar-07-2011
8	Greiner Bio-One North America, Inc.	II	Feb-22-2012
9	Greiner Bio-One North America, Inc.	II	Nov-14-2011
10	Greiner Bio-One North America, Inc.	II	Dec-16-2010
11	Greiner Bio-One North America, Inc.	III	Nov-07-2008
12	Heritage Labs International LLC	II	Jan-11-2012
13	Immunetech Inc	II	Nov-25-2011
14	StatSpin, Inc., dba Iris Sample Processing	II	Aug-23-2008
15	Whatman, Inc.	II	Sep-07-2010
16	Whatman, Inc.	III	Mar-05-2010
17	Whatman, Inc.	II	Sep-30-2009