Catheter Introducer Kit
FDA product code OFD · Class II (moderate risk) · 21 CFR 870.1340 · Cardiovascular
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.
0510(k) clearances
0PMA approvals
7recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2538-2026 Class II | Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2996-2024 Class II | Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2744-2024 Class II | Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2195-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2304-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-0751-2023 Class II | Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction…XXX | Medical Action Industries, Inc. 306 | 11/04/2022Terminated |
| Z-0016-2012 | DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer:…The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently… | Deroyal Industries, Inc. Lafollette | 08/23/2011Terminated |