Dispenser, Liquid Medication
FDA product code KYX · Class I (low risk) · 21 CFR 880.6430 · General Hospital
11510(k) clearances
0PMA approvals
17recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143177 | KleenGel DispenserKYX · Traditional | Kleengel, LLC | 09/14/2015SE |
| K980109 | Cyclotech Cyclosporine Oral Solutions DispenserKYX · Traditional | Sangstat Medical Corp. | 08/18/1998SE |
| K954181 | Canyons Bi-Directional Check ValveKYX · Traditional | Canyon Medical Products | 11/29/1995SE |
| K830571 | Bottle AdapterKYX · Traditional | Burron Medical Products, Inc. | 03/24/1983SE |
| K801008 | Multi-Ad Fluid Dispensing Pump MP-3000KYX · Traditional | Burron Medical Products, Inc. | 06/02/1980SE |
| K800437 | Syringe Tip ConnectorKYX · Traditional | Burron Medical Products, Inc. | 03/12/1980SE |
| K800362 | Fluid Dispensing SystemKYX · Traditional | Pharmaseal Laboratories | 03/12/1980SE |
| K792227 | Multi-Ad Fluid Dispensing SystemKYX · Traditional | National Patent Development Corp. | 12/20/1979SE |
| K781364 | Pint Bottle WellKYX · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 10/17/1978SE |
| K771539 | StepperKYX · Traditional | Tridak | 10/07/1977SE |
| K760517 | Cup, Disposable MedicineKYX · Traditional | Landmark Plastics | 11/12/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2037-2024 Class III | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions:…The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped… | Avanos Medical, Inc. | 03/04/2024Open, Classified |
| Z-2036-2024 Class III | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.…The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped… | Avanos Medical, Inc. | 03/04/2024Open, Classified |
| Z-2035-2024 Class III | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.…The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped… | Avanos Medical, Inc. | 03/04/2024Open, Classified |
| Z-1420-2023 Class II | ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication…ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. | Baxter Healthcare Corporation | 03/20/2023Open, Classified |
| Z-1581-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF…There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-1580-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-1579-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF…There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-1578-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF…There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-1577-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-1576-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF…There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-1575-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF…There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Baxter Healthcare Corporation | 07/22/2022Open, Classified |
| Z-0948-2022 Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100…Product is mislabeled as self-righting Luer slip tip caps, yellow. | Baxter Healthcare Corporation | 02/25/2022Terminated |
| Z-2432-2019 Class III | EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK…EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. | Baxter Healthcare Corporation | 06/27/2019Terminated |
| Z-1227-2015 Class II | Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product…Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and… | Baxter Corporation Englewood | 12/29/2014Terminated |
| Z-0871-2015 Class II | Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow…Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were… | Baxter Corporation Englewood | 12/04/2014Terminated |
| Z-1070-2012 | Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication…The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe. | Benlan, Inc. | 12/12/2011Terminated |
| Z-1097-2012 | BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL…There are complaint reports for loose tip caps in various types of oral syringes | Becton Dickinson & Company | 10/05/2011Terminated |