Catheter, Irrigation

FDA product code GBX · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery

77510(k) clearances
0PMA approvals
79recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K131659Moerae Vein Preparation KitGBX · Traditional Moerae Matrix, Inc.03/03/2014SE
K082725Graftguard Pressure Controlling SyringeGBX · Traditional Maquet Cardiovascular, LLC12/17/2008SE
K052286Deutsch Anti-Blockage Wound DrainGBX · Traditional The Catheter Exchange, Inc.10/21/2005SE
K043515GraftsaverGBX · Traditional Vescare, Inc.03/31/2005SE
K013417Misonix Irrigation System Moedl BC20PGBX · Traditional Misonix, Inc.01/10/2002SE
K000704DMC Saphenous Vein Distention System (SVDS)GBX · Traditional Dmc Medical, Ltd.05/19/2000SE
K974233Lysonix Irrigation SystemGBX · Traditional Lysonix, Inc.02/03/1998SE
K973703Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional Allegiance Healthcare Corp.12/04/1997SE
K972635Ultracell Suction SpongeGBX · Traditional Ultracell Medical Technologies, Inc.10/01/1997SE
K965146Flat Closed Wound Drain with TrocarGBX · Traditional Axiom Medical, Inc.03/10/1997SE
K961295Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional Sil-Med Corp.06/26/1996SE
K961147Closed Fluid Collection SystemGBX · Traditional B.Braun Medical, Inc.05/31/1996SE
K960955Jackson-Pratt Gold Wound Drains with Duraflo II CoatingGBX · Traditional Baxter Healthcare Corp05/22/1996SE
K955339Hydrology 5000GBX · Traditional Northgate Technologies, Inc.03/13/1996SE
K955474Neo-PneumocathGBX · Traditional Intra Special Catheters GmbH02/13/1996SE
K955505Opti-Drain Multi-Use Drainage CatheterGBX · Traditional Navarre Biomedical , Ltd.02/07/1996SE
K955439The Reel Thing (Modification)GBX · Traditional Biomedical Devices, Inc.12/26/1995SE
K926496Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional Sil-Med Corp.05/24/1995SE
K951907Navarre Locking Pigtail Universal Drainage CatheterGBX · Traditional Navarre Biomedical , Ltd.05/15/1995SE
K951475Navarre Universal Drainage CatheterGBX · Traditional Navarre Biomedical , Ltd.04/24/1995SE
K950439Insyte Sideholded Drainage CatheterGBX · Traditional Becton Dickinson Vascular Access, Inc.03/14/1995SE
K950437Angiocath Sideholder Drainage CatheterGBX · Traditional Becton Dickinson Vascular Access, Inc.03/14/1995SE
K942335Aci Silicath Thoracic CatheterGBX · Traditional American Catheter08/09/1994SE
K925243Deknatel(Tm) Pleur-Evac(R) Thoracic CatheterGBX · Traditional Deknatel, Inc.07/27/1994SE
K940156The Reel ThingGBX · Traditional Bio-Medical Devices, Inc.06/07/1994SE
K942274Orion Suction Catheter Kit with Sterile SalineGBX · Traditional Regulatory & Marketing Services, Inc.06/02/1994SEKD
K942273Orion Suction Catheter Kit with Sterile WaterGBX · Traditional Regulatory & Marketing Services, Inc.06/02/1994SEKD
K935531Op-Flex Sump Suction Set with Diffuser TipGBX · Traditional Puritas Health Care, Inc.05/05/1994SE
K940352Storz N5941 Series Medical Grade TubingGBX · Traditional Storz Instrument Co.04/14/1994SE
K933600Navarre Biomedical Tip-Locking Drainage CathetersGBX · Traditional Navarre Biomedical , Ltd.03/28/1994SE
K926495Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional Sil-Med Corp.02/02/1994SE
K926408Sil-Slip Flat Suction DrainGBX · Traditional Sil-Med Corp.02/02/1994SE
K932391Navarre Biomedical Universal Drainage Catheter SetGBX · Traditional Navarre Biomedical , Ltd.01/27/1994SE
K932205Ercp Catheter, Hydrophilic CoatedGBX · Traditional Wilson-Cook Medical, Inc.01/03/1994SE
K925117Uresil Abscess Drianage and Irrigation SetGBX · Traditional Uresil Corp.08/11/1993SE
K926109Fluid Drainage TrayGBX · Traditional Symbiosis Corp.06/07/1993SEKD
K930551Kendall Universal Extension SetGBX · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health05/12/1993SE
K923667Irrigation/Suction ProbeGBX · Traditional Surgical Instrument, Inc.04/23/1993SE
K925176Vansonnenberg Chest Drainage Catheter All PurposeGBX · Traditional Boston Scientific Corp04/08/1993SE
K925805Kendall Wound Drainage Systems-TrocarsGBX · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health02/26/1993SE
K925748Kendall Flat/Round & Flat Splittable Silicon DrainGBX · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health01/13/1993SE
K925533Angestat(R) Pericardial Drainage Sheath SetGBX · Traditional Angeion Corp.01/12/1993SE
K924702Turkel Abdominal Paracentesis SystemGBX · Traditional Symbiosis Corp.01/12/1993SE
K921424Sil-Med Flat Suction DrainGBX · Traditional Sil-Med Corp.09/28/1992SE
K922739Hollister Horizontal Drain/Tube Attachment DeviceGBX · Traditional Hollister, Inc.08/06/1992SE
K921934IntraducerGBX · Traditional Taut, Inc.07/15/1992SE
K921095Pacer Disposable Yankauer Suction InstrumentGBX · Traditional Pacer Tool & Plastics, Inc.04/29/1992SE
K913542Thoracic Catheter with GuideGBX · Traditional Intl. Medical Devices , Ltd.01/21/1992SE
K913539Thoracic Cathter StyletGBX · Traditional Intl. Medical Devices , Ltd.01/21/1992SE
K910245I/A Handpiece with Replaceable TipsGBX · Traditional Surgical Technologies, Inc.04/22/1991SE
K905614Jackson-Pratt, High Lubricity and Wound DrainsGBX · Traditional Baxter Healthcare Corp03/20/1991SE
K905766Drainage Tube Restraint/Wound CoverGBX · Traditional M. Imonti and Associates Inc.,03/06/1991SE
K905422PVC Round Wound DrainsGBX · Traditional Axiom Medical, Inc.02/11/1991SE
K904133Disposable Fluid Collection BagGBX · Traditional Axiom Medical, Inc.10/11/1990SE
K895756Mikro-AquapuratorGBX · Traditional Mikro-Tek Laboratories12/27/1989SE
K895755MIKRO-LAVAGE-1GBX · Traditional Mikro-Tek Laboratories12/27/1989SE
K895516Cavity Drainage Catheterization Set, CS-01600GBX · Traditional Arrow Intl., Inc.12/27/1989SE
K895757Irri-EvacuatorGBX · Traditional Mikro-Tek Laboratories10/19/1989SE
K883474Thoracic CathetersGBX · Traditional Westmark, Sterile Packing Systems, Inc. (Sps)09/13/1988SE
K870704Closed Paracentesis System W/Boasberg Catheter SetGBX · Traditional American Pharmaseal Div. Ahsc03/27/1987SESD
K844809Continuous VentilatorGBX · Traditional Hamilton Medical, Inc.06/27/1985SE
K852143Hall Irrigation SystemGBX · Traditional Hall Surgical, Division of Zimmer, Inc.06/26/1985SE
K844876Pennine Nelaton Catheters Sizes 5,6,8,10,12,14,16,GBX · Traditional Pennine Medical , Ltd.06/05/1985SE
K844061Microtek Irrigation SystemGBX · Traditional Microtek Medical, Inc.05/21/1985SE
K851475Vygon Cannula for Surgical Suction Yan Kauer 574/5GBX · Traditional Vygon Corp.05/03/1985SE
K844922Perimeter Thoracic CatheterGBX · Traditional Perimeter Medical, Inc.03/18/1985SE
K844094Pruitt Irrigation and Occlusion CatheterGBX · Traditional Bionomy, Inc.11/29/1984SE
K843617SDC Silicone Sump DrainGBX · Traditional Science Development Corp.10/24/1984SE
K841362Tidal Distension Irrigation SetGBX · Traditional Abbott Laboratories08/02/1984SE
K840323Silicone Suction & Irrigation DrainGBX · Traditional Superior Plastic Products Corp.04/25/1984SE
K830859I/A KitGBX · Traditional Surgeon Surgical Instrumentation, Inc.05/02/1983SE
K823496Arthroscopic Irrigation SETS-2C4030/31GBX · Traditional Travenol Laboratories, S.A.12/28/1982SE
K822510Suction Catheter W/Sterile WaterGBX · Traditional Medine Dynacor10/13/1982SE
K780788Irrigation CatheterGBX · Traditional Shiley, Inc.06/22/1978SE
K771079Curity Irrigation TrayGBX · Traditional Kendall Research Center09/15/1977SE
K770706Catheter, IrrigationGBX · Traditional Mallinckrodt Critical Care05/06/1977SE
K770442Sump Drain, W/Filter, Argyle EdlichGBX · Traditional Sherwood Medical Industries03/30/1977SE

Recalls

RecallProductFirmInitiated
Z-1790-2026 Class IICOOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Cook Incorporated03/05/2026Open, Classified
Z-0955-2026 Class IIBrand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… Rocket Medical Plc11/07/2025Open, Classified
Z-0954-2026 Class IIBrand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… Rocket Medical Plc11/07/2025Open, Classified
Z-0953-2026 Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard…IFU and device kit labeling contains misleading statements leading to improper securing of the device… Rocket Medical Plc11/07/2025Open, Classified
Z-0952-2026 Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… Rocket Medical Plc11/07/2025Open, Classified
Z-0951-2026 Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard…IFU and device kit labeling contains misleading statements leading to improper securing of the device… Rocket Medical Plc11/07/2025Open, Classified
Z-0950-2026 Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… Rocket Medical Plc11/07/2025Open, Classified
Z-1739-2024 Class IIJackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… Cardinal Health 200, LLC03/27/2024Open, Classified
Z-1738-2024 Class IIJackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… Cardinal Health 200, LLC03/27/2024Open, Classified
Z-1737-2024 Class IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… Cardinal Health 200, LLC03/27/2024Open, Classified
Z-1736-2024 Class IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… Cardinal Health 200, LLC03/27/2024Open, Classified
Z-1735-2024 Class IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… Cardinal Health 200, LLC03/27/2024Open, Classified
Z-0996-2023 Class IIVasoshield Syringe Packs, Model VH-5001Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient.… Maquet Cardiovascular, LLC12/22/2022Open, Classified
Z-0994-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0993-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0992-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0991-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0990-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0989-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0988-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0987-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0986-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0985-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0984-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0983-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0982-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0981-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0980-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0979-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0978-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0977-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0976-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0975-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0974-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0973-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0972-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0971-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0970-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0969-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0968-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0967-2023 Class IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal… Cardinal Health 200, LLC12/14/2022Open, Classified
Z-0105-2022 Class IIThoraguard Chest Tube Kit, 20 FrAn adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. Centese Inc.08/31/2021Terminated
Z-1298-2021 Class IIPLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a…Teleflex is recalling this product due to a lack of assurance of sterility. Teleflex Medical Inc02/12/2021Terminated
Z-2922-2020 Class IIPleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to…Potential sterility issue Teleflex Medical Inc08/07/2020Terminated
Z-1565-2020 Class IIPericardiocentesis Set, Irrigation Catheter, Reference Part Number…The printed expiration dates are incorrect. Cook Inc.03/06/2020Terminated
Z-2267-2019 Class IISmith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… Degania Silicone, Ltd.06/28/2019Terminated
Z-2266-2019 Class IIMedline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… Degania Silicone, Ltd.06/28/2019Terminated
Z-2265-2019 Class IICardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… Degania Silicone, Ltd.06/28/2019Terminated
Z-2264-2019 Class IICardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… Degania Silicone, Ltd.06/28/2019Terminated
Z-2263-2019 Class IICardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… Degania Silicone, Ltd.06/28/2019Terminated