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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
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
2020 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Filling Problem 1 1
Loose or Intermittent Connection 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Needle Stick/Puncture 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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