TPLC - Total Product Life Cycle

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Device	angiography/angioplasty kit
Regulation Description	Angiographic injector and syringe.
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 Code	OEQ
Regulation Number	870.1650
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unsealed Device Packaging	141	141
Tear, Rip or Hole in Device Packaging	119	119
Material Separation	28	28
No Apparent Adverse Event	27	27
Manufacturing, Packaging or Shipping Problem	21	21
Packaging Problem	21	21
Material Frayed	16	16
Device Contaminated During Manufacture or Shipping	11	11
Fracture	11	11
Connection Problem	10	10
Break	8	8
Material Integrity Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Fluid/Blood Leak	8	8
Appropriate Term/Code Not Available	7	7
Contamination /Decontamination Problem	6	6
Material Fragmentation	6	6
Contamination	5	5
Leak/Splash	4	4
Degraded	4	4
Delivered as Unsterile Product	4	4
Loose or Intermittent Connection	3	3
Mechanical Problem	2	2
Incomplete or Missing Packaging	2	2
Defective Component	2	2
Inflation Problem	2	2
Malposition of Device	1	1
Physical Resistance/Sticking	1	1
Incomplete or Inadequate Connection	1	1
Crack	1	1
Material Puncture/Hole	1	1
Air/Gas in Device	1	1
Material Discolored	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Gas/Air Leak	1	1
Product Quality Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Component Misassembled	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	375	375
Insufficient Information	9	9
Foreign Body In Patient	7	7
No Known Impact Or Consequence To Patient	6	6
Air Embolism	5	5
No Consequences Or Impact To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Perforation	3	3
Reaction	2	2
Hemorrhage/Bleeding	2	2
Low Blood Pressure/ Hypotension	2	2
No Patient Involvement	1	1
Perforation of Vessels	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems	II	May-29-2020
2	American Contract Systems Inc	II	Mar-14-2025
3	American Contract Systems Inc.	II	Oct-16-2025
4	American Contract Systems, Inc.	II	Sep-24-2024
5	American Contract Systems, Inc.	II	Aug-07-2024
6	American Contract Systems, Inc.	II	Sep-08-2022
7	Cardinal Health 200, LLC	II	Jul-10-2024
8	Cardinal Health 200, LLC	II	Mar-15-2021
9	DeRoyal Industries Inc	II	Jul-03-2023
10	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
11	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-25-2025
12	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-21-2025
13	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
14	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-27-2024
15	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
16	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
17	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-10-2023
18	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
19	Medline Industries Inc	II	Oct-07-2020
20	Merit Medical Systems, Inc.	II	Oct-11-2024
21	Merit Medical Systems, Inc.	II	Sep-20-2024
22	Merit Medical Systems, Inc.	II	Aug-12-2024
23	Merit Medical Systems, Inc.	II	Dec-29-2020
24	Merit Medical Systems, Inc.	II	Apr-13-2020
25	ROi CPS LLC	II	Sep-17-2024
26	Stradis Medical, LLC dba Stradis Healthcare	II	Dec-14-2022