Accessories, Catheter
FDA product code KGZ · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery
29510(k) clearances
0PMA approvals
21recalls
Manufacturers
- B. Braun Instruments 3
- Arrow Intl., Inc. 2
- Conphar, Inc. 2
- Quinton, Inc. 2
- Warner-Lambert Co. 2
- Intl. Medical Devices , Ltd. 1
- Aesthetic and Reconstructive Technologies, Inc. 1
- Allied Biomedical Corp. 1
- Navarre Biomedical , Ltd. 1
- North American Instrument Corp. 1
- Medical Dynamics, Inc. 1
- Deseret Medical, Inc. 1
- Concept, Inc. 1
- Health Care Innovations, Inc. 1
- Cathaid, Inc. 1
- Angiomed U.S., Inc. 1
- Sherwood Medical Co. 1
- Biochem International, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Argon Medical Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022306 | Aart Silicone TubingKGZ · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 10/10/2002SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | Byron Medical | 02/10/1998SE |
| K973183 | Wound Drainage HolderKGZ · Traditional | R & D Medical Products, Inc. | 01/23/1998SE |
| K955433 | Duralastic Silicone TubingKGZ · Traditional | Allied Biomedical Corp. | 01/26/1996SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | Navarre Biomedical , Ltd. | 07/08/1994SE |
| K896087 | Palestrant Irrigation and Drainage SetKGZ · Traditional | North American Instrument Corp. | 11/03/1989SE |
| K895041 | Optical Catheter(Tm) Introducer SetsKGZ · Traditional | Medical Dynamics, Inc. | 10/16/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
| K873009 | Concept Switching StickKGZ · Traditional | Concept, Inc. | 08/17/1987SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
| K864115 | Tubegripper, Drainage Catheter & Accessory for SuKGZ · Traditional | Cathaid, Inc. | 11/07/1986SE |
| K855078 | Angio Med Disposable Pressure ConnectorsKGZ · Traditional | Angiomed U.S., Inc. | 02/19/1986SE |
| K842666 | Nu-Thor Thoracostomy KitKGZ · Traditional | Intl. Medical Devices , Ltd. | 09/20/1984SE |
| K821525 | Deseret Universal Luer LockKGZ · Traditional | Warner-Lambert Co. | 06/23/1982SE |
| K821245 | Deseret Offset PRN AdapterKGZ · Traditional | Warner-Lambert Co. | 05/13/1982SE |
| K810531 | Peri-Patch Peritoneal Catheter ExtensionKGZ · Traditional | Quinton, Inc. | 03/24/1981SE |
| K810530 | Peri-Patch Glue MoldKGZ · Traditional | Quinton, Inc. | 03/24/1981SE |
| K802367 | Arrow Catheter ClampKGZ · Traditional | Arrow Intl., Inc. | 10/23/1980SE |
| K802286 | Argle Latex Penrose TubingKGZ · Traditional | Sherwood Medical Co. | 10/23/1980SE |
| K791806 | Conphar Adapt-Connects Sterile, Nonste.KGZ · Traditional | Conphar, Inc. | 09/21/1979SE |
| K791803 | Conphar Catheter PlugKGZ · Traditional | Conphar, Inc. | 09/21/1979SE |
| K790597 | Sensomat Sidearm AdapterKGZ · Traditional | Biochem International, Inc. | 07/10/1979SE |
| K781846 | Adapter, Catheter SheathKGZ · Traditional | Arrow Intl., Inc. | 12/12/1978SE |
| K781854 | Pad, B-D I.V. Cath.KGZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/04/1978SE |
| K780259 | Catheterization Tray & KitKGZ · Traditional | Argon Medical Corp. | 04/18/1978SE |
| K770154 | 3-WAY Stopcock with Luer-Lock FittingKGZ · Traditional | American Viggo | 02/28/1977SE |
| K760385 | Extension SetsKGZ · Traditional | B. Braun Instruments | 11/02/1976SE |
| K760384 | StoppersKGZ · Traditional | B. Braun Instruments | 11/02/1976SE |
| K760383 | StopcocksKGZ · Traditional | B. Braun Instruments | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0681-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0680-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0679-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-1731-2025 Class II | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in…Due to a potential open seal in the sterile barrier packaging . | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-0568-2021 Class II | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis…Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more… | Galt Medical Corporation | 11/16/2020Terminated |
| Z-1780-2019 Class II | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NTThe products may have been manufactured without the bottom seal on the outer packaging, compromising the… | Cook Inc. | 05/02/2019Terminated |
| Z-2249-2018 Class II | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF…The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential… | Vascular Solutions, Inc. | 05/04/2018Terminated |
| Z-2564-2018 Class II | TVS LPA, Catalog #: DIL-059-00The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | Galt Medical Corporation | 05/02/2018Terminated |
| Z-2563-2018 Class II | Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | Galt Medical Corporation | 05/02/2018Terminated |
| Z-2560-2018 Class II | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b)…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | Galt Medical Corporation | 05/02/2018Terminated |
| Z-2030-2018 Class II | Extension Line Slide Clamps; Product codes: SA-09847Product sterility may be compromised due to unsealed packaging. | Arrow International Inc | 04/11/2018Terminated |
| Z-1389-2017 Class II | Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | Cook Inc. | 02/01/2017Terminated |
| Z-1817-2017 Class II | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445.…The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the… | Micromedics, Inc. | 10/20/2016Terminated |
| Z-2620-2016 Class II | Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | Cook Inc. | 04/15/2016Terminated |
| Z-2619-2016 Class II | Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | Cook Inc. | 04/15/2016Terminated |
| Z-0162-2011 | IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress…Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled… | LifeCell Corporation | 09/13/2010Terminated |
| Z-2274-2010 | Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for…Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed… | Arrow International Inc | 06/07/2010Terminated |
| Z-1538-2010 | Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for…Some central venous catheter sets had the incorrect lid stock. | Arrow International Inc | 12/15/2009Terminated |
| Z-0521-2010 | Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device…Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-1493-2009 | Arrow Percutaneous Sheath IntroducersLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | Arrow International Inc | 02/11/2009Terminated |
| Z-1169-2009 | Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray…Lack of assurance of sterility, as the package seals may be inadequate. | Tri-State Hospital Supply Corporation | 01/14/2009Terminated |