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Catheter Introducer Kit

FDA product code OFD · Class 2 · Cardiovascular

218
Registered devices
6
Adverse events
7
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-05-21Medline Industries, LPThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocai
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2023-05-18MEDLINE INDUSTRIES, LP - NorthfieldProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15MEDLINE INDUSTRIES, LP - NorthfieldPotential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2022-11-04Medical Action Industries, Inc. 306XXX
2011-08-23Deroyal Industries, Inc. LafolletteThe firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that c

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.