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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter introducer kit
Regulation Description Catheter introducer.
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. The 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 CodeOFD
Regulation Number 870.1340
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 1 1
Appropriate Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
5 Medical Action Industries, Inc. 306 II Dec-21-2022
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