I.v. Start Kit
General Hospital · 21 CFR 880.5200
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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
315 adverse event reports on file
- ARROW CVC KIT: 16 GA X 8 INJul 30, 2026MalfunctionArrow International Llc9680794-2026-00545
- ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGBJul 27, 2026MalfunctionArrow International Llc9680794-2026-00536
- ARROW CVC SET: 3-LUMEN 7 FR X 20 CMJul 27, 2026MalfunctionArrow International Llc3006425876-2026-00786
- ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB+Jul 27, 2026MalfunctionArrow International Llc9680794-2026-00543
- ARROW CVC SET: 3-LUMEN 7 FR X 20 CMJul 20, 2026MalfunctionArrow International Llc3006425876-2026-00768
- ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGBJul 15, 2026MalfunctionArrow International Llc9680794-2026-00521
- MEDLINEJul 13, 2026MalfunctionTri-state De Mexico, S. De R.l De C.v3004519921-2026-00035
- ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGBJul 8, 2026MalfunctionArrow International Llc9680794-2026-00514
- ARROW CVC SET: 3-LUMEN 7 FR X 20 CMJul 8, 2026MalfunctionArrow International Llc3006425876-2026-00738
- ARROW CVC SET: 3-LUMEN 7 FR X 20 CMJul 8, 2026MalfunctionArrow International Llc3006425876-2026-00737
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Break”
Recalls
162 recall events for this product code
- Medline Industries, LPOpen, ClassifiedJun 29, 2026
Medline Convenience Kits:
The 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 Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Z-2543-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2375-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2376-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2384-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 12, 2026
Medline convenience kit:
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Z-2425-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedMay 7, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2118-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedApr 30, 2026
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Z-2043-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedApr 22, 2026
Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Z-1915-2026 · View FDA record ↗ - LSL Healthcare Inc.Open, ClassifiedApr 22, 2026
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Z-1932-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 17, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-1401-2026 · View FDA record ↗
Registered firms
74 firms currently registered for this product code
Isomedix Operations Inc.
Northborough, MA, US
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Carefusion 2200, Inc.
Vernon Hills, IL, US
Sterigenics U.s., Llc
Queensbury, NY, US
Midwest Sterilization Corp.
LAREDO, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Sterigenics U.s., Llc
Ontario, CA, US
Vygon Mfg
DOVER, NH, US
Sterigenics Us Llc
Grand Prairie, TX, US
Safeguard Us Operating, Llc
Huntersville, NC, US
Su Biyomedikal Sistemler Ve Saglik Hiz. San. Ve Tic. A. S.
Tekirdag, TR
Synchronis Medical Llc
Romulus, MI, US
Lsl Healthcare
Niles, IL, US
Becton Dickinson Infusion Therapy Systems Inc.
Sandy, UT, US
Nar Medical Depot, Llc
Greer, SC, US
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
Vygon Usa
Lansdale, PA, US
Cardinal Health 200, Llc
El Paso, TX, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Chinook Medical Gear, Inc.
Tulsa, OK, US
510(k) clearances
30 clearances for this product code
- Amsino International, Inc.May 2, 2005
K050654 · AMSINO I.V. START KIT
- Nirvi Intl. USANov 20, 2001
K001879 · INFUSION IV SET
- Grand Medical ProductsNov 27, 1996
K963722 · IV START KIT
- Emergency Medical Supply, Inc.May 16, 1995
K951167 · EMS I.V. START KIT
- B. Braun of America, Inc.Mar 15, 1995
K950184 · B. BRAUN IV START KITS
- Resound Corp.Dec 27, 1994
K944041 · PERSONAL HEARING SYSTEM
- Becton Dickinson Vascular Access, Inc.Oct 20, 1994
K943941 · SAFESTART VASCULAR ACCESS START KIT
- Cush Medical ProductsJun 10, 1994
K935684 · IV START KIT