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
Tear, Rip or Hole in Device Packaging	126	126
Unsealed Device Packaging	103	103
Material Separation	29	29
Packaging Problem	26	26
Manufacturing, Packaging or Shipping Problem	26	26
Material Frayed	14	14
Fracture	12	12
Device Contaminated During Manufacture or Shipping	11	11
Connection Problem	11	11
Break	9	9
Material Integrity Problem	9	9
Fluid/Blood Leak	8	8
Appropriate Term/Code Not Available	7	7
Contamination	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Leak/Splash	4	4
Delivered as Unsterile Product	4	4
Loose or Intermittent Connection	3	3
Incomplete or Missing Packaging	3	3
No Apparent Adverse Event	3	3
Product Quality Problem	2	2
Inflation Problem	2	2
Material Fragmentation	2	2
Defective Device	2	2
Defective Component	2	2
Mechanical Problem	2	2
Material Discolored	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Gas/Air Leak	1	1
Air/Gas in Device	1	1
Contamination /Decontamination Problem	1	1
Insufficient Information	1	1
Material Puncture/Hole	1	1
Device Damaged Prior to Use	1	1
Component Misassembled	1	1
Crack	1	1
Incomplete or Inadequate Connection	1	1
Physical Resistance/Sticking	1	1
Component or Accessory Incompatibility	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	348	348
Insufficient Information	9	9
Foreign Body In Patient	7	7
Air Embolism	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Perforation	3	3
Hemorrhage/Bleeding	2	2
Low Blood Pressure/ Hypotension	2	2
Perforation of Vessels	1	1
Unspecified Heart Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems Inc	II	Mar-14-2025
2	American Contract Systems Inc.	II	Oct-16-2025
3	American Contract Systems, Inc.	II	Sep-24-2024
4	American Contract Systems, Inc.	II	Aug-07-2024
5	American Contract Systems, Inc.	II	Sep-08-2022
6	Cardinal Health 200, LLC	II	Jul-10-2024
7	Cardinal Health 200, LLC	II	Mar-15-2021
8	DeRoyal Industries Inc	II	Jul-03-2023
9	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
10	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-25-2025
11	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-21-2025
12	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
13	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-27-2024
14	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
15	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
16	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-10-2023
17	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
18	Medline Industries, LP	I	May-08-2026
19	Medline Industries, LP	II	May-07-2026
20	Medline Industries, LP	II	Apr-30-2026
21	Medline Industries, LP	II	Apr-17-2026
22	Medline Industries, LP	II	Apr-17-2026
23	Medline Industries, LP	I	Apr-07-2026
24	Medline Industries, LP	II	Feb-17-2026
25	Merit Medical Systems, Inc.	II	Apr-29-2026
26	Merit Medical Systems, Inc.	II	Jan-16-2026
27	Merit Medical Systems, Inc.	II	Oct-11-2024
28	Merit Medical Systems, Inc.	II	Sep-20-2024
29	Merit Medical Systems, Inc.	II	Aug-12-2024
30	ROi CPS LLC	II	Sep-17-2024
31	Stradis Medical, LLC dba Stradis Healthcare	II	Dec-14-2022