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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device peripheral catheter insertion 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 www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOWL
Regulation Number 880.5200
Device Class 2

MDR Year MDR Reports MDR Events
2021 4 4
2023 6 6
2024 2 2
2025 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4 4
Fluid/Blood Leak 4 4
Crack 2 2
Break 1 1
Physical Resistance/Sticking 1 1
Material Puncture/Hole 1 1
Unsealed Device Packaging 1 1
Patient Device Interaction Problem 1 1
Air/Gas in Device 1 1
Blocked Connection 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Failure of Implant 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LSL Healthcare Inc. II Jan-29-2026
2 Medical Action Industries, Inc. 306 II Dec-08-2022
3 Stradis Healthcare II Jan-11-2023
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