TPLC - Total Product Life Cycle

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Device	i.v. start kit
Regulation Description	Intravascular catheter.
Definition	This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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	LRS
Regulation Number	880.5200
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	23	23
Fluid/Blood Leak	13	13
Break	13	13
Crack	13	13
Material Twisted/Bent	9	9
Detachment of Device or Device Component	8	8
Component Missing	8	8
Loose or Intermittent Connection	7	7
Appropriate Term/Code Not Available	7	7
Defective Device	7	7
Material Integrity Problem	7	7
Loss of or Failure to Bond	6	6
Physical Resistance/Sticking	5	5
Insufficient Information	5	5
Material Separation	5	5
Product Quality Problem	4	4
Infusion or Flow Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Material Split, Cut or Torn	3	3
Connection Problem	3	3
Patient-Device Incompatibility	3	3
Unraveled Material	3	3
Gas/Air Leak	3	3
Packaging Problem	3	3
Failure to Seal	2	2
Deformation Due to Compressive Stress	2	2
Device Markings/Labelling Problem	2	2
Separation Failure	2	2
Device Dislodged or Dislocated	2	2
Patient Device Interaction Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Sharp Edges	2	2
Material Deformation	2	2
Improper or Incorrect Procedure or Method	1	1
Component Incompatible	1	1
Migration	1	1
Activation Failure	1	1
Difficult or Delayed Positioning	1	1
Lack of Effect	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Difficult to Insert	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Component	1	1
Material Puncture/Hole	1	1
Complete Blockage	1	1
Peeled/Delaminated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	115	115
Insufficient Information	36	36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Needle Stick/Puncture	5	5
Abrasion	4	4
Hemorrhage/Bleeding	4	4
Local Reaction	2	2
Burn(s)	2	2
Laceration(s)	2	2
Pain	2	2
Unspecified Tissue Injury	2	2
Swelling/ Edema	2	2
Infiltration into Tissue	2	2
Hypersensitivity/Allergic reaction	1	1
Foreign Body In Patient	1	1
Dyspnea	1	1
Anaphylactic Shock	1	1
Tachycardia	1	1
Contact Dermatitis	1	1
Hypoxia	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL, LLC	II	Apr-22-2026
2	Busse Hospital Disposables, Inc.	II	May-28-2022
3	Cardinal Health 200, LLC	II	Feb-22-2023
4	LSL Healthcare Inc.	II	Apr-22-2026
5	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-21-2025
6	MEDLINE INDUSTRIES, LP - Northfield	II	Jun-30-2025
7	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
8	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
9	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
10	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-28-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-28-2024
12	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
13	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
14	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
15	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
16	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
17	Medical Action Industries, Inc. 306	II	Mar-28-2024
18	Medline Industries, LP	II	May-07-2026
19	Medline Industries, LP	II	Apr-30-2026
20	Medline Industries, LP	II	Feb-17-2026
21	Medline Industries, LP	II	Jan-12-2026
22	ROi CPS LLC	II	Apr-26-2022
23	ROi CPS LLC	III	Mar-30-2022
24	Resource Optimization & Innovation LLC	II	Apr-18-2022
25	Stradis Healthcare	II	Jan-11-2023