I.V. Start Kit
FDA product code LRS · Class II (moderate risk) · 21 CFR 880.5200 · General Hospital
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.
30510(k) clearances
0PMA approvals
165recalls
Manufacturers
- Customed, Inc 2
- Cypress Medical Products, Ltd. 1
- Amsino International, Inc. 1
- Clinical Resources, Inc. 1
- Electone, Inc. 1
- Medi-Flex Hospital Products, Inc. 1
- Cml, Inc. 1
- Trinity Laboratories, Inc. 1
- Transidyne General Corp. 1
- Brigam Medical, Inc. 1
- Specialty Medical Products Co. 1
- Sherwood Medical Industries 1
- Ni-Med, Inc. 1
- Telstar Electronics, Inc. 1
- The Jarid Group, Inc. 1
- American Biomaterials Corp. 1
- Busse Hospital Disposables, Inc. 1
- Ferris Mfg. Corp. 1
- Packaging Technologies, Inc. 1
- The Kendal Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050654 | Amsino I.V. Start KitLRS · Traditional | Amsino International, Inc. | 05/02/2005SE |
| K001879 | Infusion IV SetLRS · Traditional | Nirvi Intl. USA | 11/20/2001SE |
| K963722 | IV Start KitLRS · Traditional | Grand Medical Products | 11/27/1996SE |
| K951167 | EMS I.V. Start KitLRS · Traditional | Emergency Medical Supply, Inc. | 05/16/1995SN |
| K950184 | B. Braun IV Start KitsLRS · Traditional | B. Braun of America, Inc. | 03/15/1995SEKD |
| K944041 | Personal Hearing SystemLRS · Traditional | Resound Corp. | 12/27/1994SE |
| K943941 | Safestart Vascular Access Start KitLRS · Traditional | Becton Dickinson Vascular Access, Inc. | 10/20/1994SE |
| K935684 | IV Start KitLRS · Traditional | Cush Medical Products | 06/10/1994SEKD |
| K942238 | I.V. Startpak Vascular Access Start KitLRS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/03/1994SE |
| K941469 | IV Start KitLRS · Traditional | Clinical Resources, Inc. | 05/12/1994SE |
| K925018 | IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional | Customed, Inc. | 08/27/1993SEKD |
| K925017 | IV Prep Kit (Non-Sterile)LRS · Traditional | Customed, Inc. | 08/27/1993SE |
| K933041 | Cold CD Asp Module, IteLRS · Traditional | Electone, Inc. | 08/02/1993SE |
| K930196 | Cepti-Seal I.V. Prep KitLRS · Traditional | Medi-Flex Hospital Products, Inc. | 07/02/1993SEKD |
| K924538 | IV Start KitLRS · Traditional | Cml, Inc. | 07/02/1993SEKD |
| K923361 | I.V. Start Kit, Sterile, DisposableLRS · Traditional | Trinity Laboratories, Inc. | 06/28/1993SEKD |
| K924811 | I.V. Start KitLRS · Traditional | Transidyne General Corp. | 06/17/1993SEKD |
| K926031 | Pro-Prep I.V. Start/Scrub-Prep/Blood Culture KitLRS · Traditional | Brigam Medical, Inc. | 06/07/1993SEKD |
| K922533 | IV Start Kit Custom SMP # A-ZLRS · Traditional | Specialty Medical Products Co. | 03/23/1993SEKD |
| K914475 | IV Start KitLRS · Traditional | Cypress Medical Products, Ltd. | 03/18/1992SEKD |
| K875315 | I.V. Start KitsLRS · Traditional | Ni-Med, Inc. | 02/17/1988SESD |
| K871731 | Telstar Prewire SeriesLRS · Traditional | Telstar Electronics, Inc. | 10/27/1987SE |
| K871281 | IV Start KitLRS · Traditional | The Jarid Group, Inc. | 05/27/1987SE |
| K863796 | Creative Care Systems' IV Start KitLRS · Traditional | American Biomaterials Corp. | 11/28/1986SE |
| K863712 | I.V. Start Kit, Sterile, DisposablesLRS · Traditional | Busse Hospital Disposables, Inc. | 10/22/1986SE |
| K852375 | I.V. Starter Tray W/Dynaderm Transparent AdhesiveLRS · Traditional | Ferris Mfg. Corp. | 07/11/1985SESD |
| K844614 | IV Start KitLRS · Traditional | Packaging Technologies, Inc. | 12/19/1984SE |
| K842898 | Curity I.V. Start KitLRS · Traditional | The Kendal Co. | 08/17/1984SE |
| K820490 | IV Start TrayLRS · Traditional | Seamless Hospital Products Co. | 03/16/1982SE |
| K760876 | Argyle IV Starter Kit (W/O Drug)LRS · Traditional | Sherwood Medical Industries | 12/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3125-2026 | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3071-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3056-2026 Class II | Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-2543-2026 Class II | Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND…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-2425-2026 Class II | Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2384-2026 Class I | Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2376-2026 Class I | Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2375-2026 Class I | Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2043-2026 Class II | Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 03/16/2026Open, Classified |
| Z-1915-2026 Class II | Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI…Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Arrow International, LLC | 03/11/2026Open, Classified |
| Z-1932-2026 Class II | LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently… | LSL Healthcare Inc. | 03/09/2026Open, Classified |
| Z-2118-2026 Class II | Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1401-2026 Class II | Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1056-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-2154-2025 Class II | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:…Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to… | MEDLINE INDUSTRIES, LP - Northfield | 06/12/2025Open, Classified |
| Z-2044-2025 Class II | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x…Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard… | MEDLINE INDUSTRIES, LP - Northfield | 05/23/2025Open, Classified |
| Z-1604-2025 Class II | Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-0168-2025 Class II | Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-3021-2024 Class II | Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, 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-2777-2024 Class II | Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY…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-2769-2024 Class II | Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100Medical 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-1394-2024 Class II | IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.The kits contain saline flush syringes which were recalled by the supplier. | Medical Action Industries, Inc. 306 | 01/15/2024Open, Classified |
| Z-1134-2024 Class I | Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-1113-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-2200-2023 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-2183-2023 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-2323-2023 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-0947-2023 Class II | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0946-2023 Class II | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0945-2023 Class II | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case.…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0943-2023 Class II | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-1159-2023 Class II | Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553EPresource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap… | Cardinal Health 200, LLC | 11/18/2022Open, Classified |
| Z-1158-2023 Class II | Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #:…Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap… | Cardinal Health 200, LLC | 11/18/2022Open, Classified |
| Z-1157-2023 Class II | Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #:…Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap… | Cardinal Health 200, LLC | 11/18/2022Open, Classified |
| Z-1080-2023 Class II | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-1615-2022 Class II | MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1006-2022 Class II | Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions…A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation… | ROi CPS LLC | 03/18/2022Terminated |
| Z-0950-2022 Class II | Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access…A kit component, the PDI Prevantics Swab, was recalled. | Resource Optimization & Innovation LLC | 02/28/2022Terminated |
| Z-0837-2022 Class III | Regard Custom Procedure Kits containing BD Luer Lok Access DevicesRecalled devices were packaged in convenience kits. | ROi CPS LLC | 02/24/2022Terminated |
| Z-1157-2022 Class II | I.V. Start Kit Catalog 8172Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1147-2022 Class II | I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-2165-2019 Class II | NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for…Potential for sterile packaging to be compromised | Centurion Medical Products Corporation | 07/01/2019Terminated |
| Z-0104-2020 Class II | IV KIT - SORBAVIEW IVS3475Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0103-2020 Class II | IV SECUREMENT KIT IVS3405Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0102-2020 Class II | IV START KIT IV8440Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0085-2020 Class II | INFUSA PORT KIT DYNDC1840FFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0077-2020 Class II | PEDIATRIC PICC INSERTION TRAY CVI4450AFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0076-2020 Class II | PEDIATRIC PICC INSERTION TRAY CVI4450Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0075-2020 Class II | PICC Line Accessory Kit CVI4285Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | Centurion Medical Products Corporation | 04/24/2019Terminated |
| Z-0933-2018 Class II | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when…The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting… | Vygon MFG, Inc., dba/ Churchill Medical… | 10/03/2017Terminated |