Intravenous Extension Tubing Set
General Hospital · 21 CFR 880.5440
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 type of 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.
Recent MDR events
39 adverse event reports on file
- SUGAN CO., LTD..OSAKA..JP.ETO.CUSTOM ANGIOGRAPHIC KIT.Jun 18, 2026MalfunctionMerit Medical Systems, Inc1721504-2026-00256
- CUSTOM KITMar 24, 2026MalfunctionMerit Medical Systems, Inc.1721504-2026-00937
- IMED 8 IV EXT 12"Sep 22, 2025MalfunctionUnkMW5176360
- CUSTOM ANGIOGRAPHIC KITMar 19, 2024InjuryMerit Medical Systems Inc.1721504-2024-00018
- CUSTOM ANGIOGRAPHIC KITMar 12, 2024MalfunctionMerit Medical Systems Inc.1721504-2024-00017
- CUSTOM ANGIOGRAPHIC KITMar 12, 2024MalfunctionMerit Medical Systems Inc.1721504-2024-00016
- CUSTOM ANGIOGRAPHIC KITMar 7, 2024MalfunctionMerit Medical Systems Inc.1721504-2024-00013
- MEDEX EXTENSION SETS MULTI LINEOct 26, 2023MalfunctionSmiths Medical International, Ltd.3012307300-2023-09940
- MEDEX EXTENSION SETS MULTI LINEDec 29, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-28303
- MEDEX EXTENSION SETS MULTI LINENov 23, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-27452
Event type breakdown
Recalls
4 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedAug 13, 2026
Cardinal Health Presource Kits:
Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.
Z-2946-2026 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedAug 12, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Z-2294-2025 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedAug 12, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2561-2024 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedAug 12, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2563-2024 · View FDA record ↗
Registered firms
31 firms currently registered for this product code
Sterilization Services Of Virginia
RICHMOND, VA, US
Argon Medical Devices Inc.
ATHENS, TX, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Vygon Usa
Lansdale, PA, US
Safeguard Us Operating, Llc
Huntersville, NC, US
Vygon Mfg
DOVER, NH, US
Waismed Ltd.
Rosh Haayin Central, IL
Isomedix Operations Inc
EL PASO, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations, Inc.
Temecula, CA, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Optum Distribution Center, Llc
Marietta, GA, US
Isomedix Operations Inc
El Paso, TX, US
Isomedix Operations Inc.
Northborough, MA, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Midwest Sterilization Corp.
LAREDO, TX, US
Merit Medical Uk Limited
Earley Reading, GB
Sterigenics Us Llc
Grand Prairie, TX, US
Merit Medical Systems, Inc.
South Jordan, UT, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Merit Medical Singapore Pte. Ltd.
SINGAPORE Central Singapore, SG
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
1 clearances for this product code