Syringe, Irrigating (Non Dental)
FDA product code KYZ · Class I (low risk) · 21 CFR 880.6960 · General Hospital
41510(k) clearances
0PMA approvals
20recalls
GMP exemptexempt from GMP rules
Manufacturers
- Micromedics, Inc. 4
- Nusurg, Inc. 2
- Contour Fabricators of Florida, Inc. 2
- Instrument Makar, Inc. 2
- Shippert Medical Technologies 2
- Sub-Q, Inc. 2
- L H M Ent., Inc. 1
- Nortech Laboratories, Inc. 1
- Zerowet Splashield 1
- Stryker Corporation 1
- Cypress Medical Products, Ltd. 1
- Physicians Supply Co. 1
- Johnson & Johnson Patient Care, Inc. 1
- Safkan, Inc. 1
- Burron Medical Products, Inc. 1
- Medcare Disp Products, Inc. 1
- Megaplast, Inc. 1
- Ackrad Laboratories 1
- Walpak Co. 1
- California Cardiac Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning SystemKYZ · Traditional | Safkan, Inc. | 11/05/2020SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | Micromedics, Inc. | 03/15/2011SE |
| K092022 | Tissu Trans Harvest TubingKYZ · Special | Shippert Medical Technologies Corp. | 08/17/2009SE |
| K050797 | Tissu-TransKYZ · Traditional | Shippert Medical Technologies Corp. | 07/13/2005SE |
| K991254 | QS Delivery SystemKYZ · Traditional | Sub-Q, Inc. | 08/23/1999SE |
| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
| K952407 | Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile WaterKYZ · Traditional | Contour Fabricators of Florida, Inc. | 08/07/1995SE |
| K952406 | Redi Nurse System (RNS) Pre-Filled 60CC Irrigation Syringe W/Sterile Sodium Chloride…KYZ · Traditional | Contour Fabricators of Florida, Inc. | 08/07/1995SE |
| K933171 | Inman Irrigation Tapered ProbeKYZ · Traditional | Inman Medical Corp. | 04/29/1994SE |
| K940371 | Surgical Sealant Applicator Tip Endoscopic TipKYZ · Traditional | Micromedics, Inc. | 04/06/1994SE |
| K930610 | Talc Dispenser SyringeKYZ · Traditional | Nusurg, Inc. | 11/04/1993SE |
| K924517 | Avitene Dispenser SyringeKYZ · Traditional | Nusurg, Inc. | 10/27/1993SE |
| K931912 | Irrigating Blunt DissectorKYZ · Traditional | Mayaguez Medical Center | 08/10/1993SE |
| K931946 | Welch Allyn EarcleanerKYZ · Traditional | Welch Allyn, Inc. | 07/26/1993SE |
| K924809 | Irrigation Tray W/ Bulb SyringeKYZ · Traditional | Customed, Inc. | 06/07/1993SEKD |
| K905173 | Splash GuardKYZ · Traditional | E.M. Adams | 04/25/1991SE |
| K905365 | Instrument Makar Gravity Assist SystemKYZ · Traditional | Instrument Makar, Inc. | 02/06/1991SE |
| K903759 | Irriclear Ear Irrigation SyringeKYZ · Traditional | Nortech Laboratories, Inc. | 10/26/1990SESK |
| K900208 | Zerowet SplashieldKYZ · Traditional | Zerowet Splashield | 09/04/1990SE |
| K902854 | Gravity AssistKYZ · Traditional | Instrument Makar, Inc. | 08/29/1990SE |
| K896800 | Irrigation TrayKYZ · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 05/24/1990SESK |
| K894470 | Stryker Trauma TrayKYZ · Traditional | Stryker Corp. | 08/18/1989SE |
| K890728 | Sterile Irrigation TraysKYZ · Traditional | Cypress Medical Products, Ltd. | 06/16/1989SESD |
| K884786 | Ear Irrigation Set 101 (Earigator)KYZ · Traditional | Physicians Supply Co. | 04/26/1989SESD |
| K884749 | Johnson & Johnson Sterile Spray Tip SyringeKYZ · Traditional | Johnson & Johnson Patient Care, Inc. | 12/15/1988SE |
| K883506 | Irrigation KitKYZ · Traditional | L H M Ent., Inc. | 12/13/1988SE |
| K883338 | Surgical Sealant ApplicatorKYZ · Traditional | Micromedics, Inc. | 08/23/1988SE |
| K881020 | Surgical Sealant Dispenser (SSD)KYZ · Traditional | Micromedics, Inc. | 03/25/1988SE |
| K830572 | Clean-FlushKYZ · Traditional | Burron Medical Products, Inc. | 03/17/1983SE |
| K821530 | Syringe IrrigatingKYZ · Traditional | Medcare Disp Products, Inc. | 05/28/1982SE |
| K813027 | Sterile Irrigating Syringes, Kits,TrayKYZ · Traditional | Welcon, Inc. | 11/20/1981SE |
| K810251 | Syringe, ENTKYZ · Traditional | Megaplast, Inc. | 03/11/1981SE |
| K810209 | IrrijetKYZ · Traditional | Ackrad Laboratories | 02/17/1981SE |
| K803200 | Irrigation Set W/Bulb SyringeKYZ · Traditional | Walpak Co. | 01/21/1981SE |
| K801573 | Sapcrill Thermodetect Breast Scanner DevKYZ · Traditional | California Cardiac Systems, Inc. | 09/09/1980SE |
| K791998 | 60CC Irrigating Syringe, Piston Type,KYZ · Traditional | Waz Industries, Inc. | 10/26/1979SE |
| K780794 | Irrigation CapKYZ · Traditional | Travenol Laboratories, S.A. | 07/27/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2725-2026 Class II | Rapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk… | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-1157-2024 Class II | Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringePackaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at… | MEDLINE INDUSTRIES, LP - Northfield | 01/04/2024Open, Classified |
| Z-1049-2024 Class I | Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | Cardinal Health 200, LLC | 12/04/2023Open, Classified |
| Z-1126-2023 Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | MEDLINE INDUSTRIES, LP - Northfield | 12/07/2022Open, Classified |
| Z-0806-2018 Class II | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code…Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the… | Baxter Healthcare Corporation | 02/06/2018Terminated |
| Z-1185-2018 Class II | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | Cook Inc. | 12/19/2017Terminated |
| Z-3062-2017 Class II | Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Shippert Medical Technologies | 06/01/2017Terminated |
| Z-3060-2017 Class II | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Shippert Medical Technologies | 06/01/2017Terminated |
| Z-0738-2017 Class II | BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | C.R. Bard, Inc. | 08/03/2016Terminated |
| Z-0737-2017 Class II | BARD Piston Syringe, 60cc, Rx Only, Sterile, The BARD Syringe is available in a single…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | C.R. Bard, Inc. | 08/03/2016Terminated |
| Z-0736-2017 Class II | BARD 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | C.R. Bard, Inc. | 08/03/2016Terminated |
| Z-0735-2017 Class II | BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | C.R. Bard, Inc. | 08/03/2016Terminated |
| Z-1400-2016 Class II | Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-0812-2016 Class III | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single…Report by a customer of an open package seal. | C.R. Bard, Inc. | 01/04/2016Terminated |
| Z-2551-2015 Class II | IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-1810-2013 Class II | Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with…Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had… | Medtronic Neurosurgery | 06/28/2013Terminated |
| Z-1252-2012 | Irrigation Tray w/Bulb syringe, catalog# 900-020The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | Customed, Inc | 12/08/2011Terminated |
| Z-0346-2011 | ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | Micromedics, Inc. | 03/15/2010Terminated |
| Z-0345-2011 | AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | Micromedics, Inc. | 03/15/2010Terminated |
| Z-1537-2012 | HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in…This product has been recalled due to the lot number being different on the box and pouch. The lot number on… | Haemacure Corporation | 11/16/2009Terminated |