Medefil, Inc.
Medical device manufacturer in Glendale Heights, IL.
7510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K121262 | Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyNGT · Special | 09/20/2012SE |
| K092491 | Medefil's Heparin I.V. Flush Syringe 1 Unit/Ml; 10 Units/Ml; and 100 Units/Ml in Various…NZW · Traditional | 02/03/2010SE |
| K091583 | Medefil's Normal Saline I.V. Flush SyringeNGT · Special | 01/28/2010SE |
| K020996 | Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…NGT · Traditional | 06/24/2002SE |
| K020999 | Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…NGT · Traditional | 06/20/2002SE |
| K993518 | Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe…FOZ · Traditional | 06/12/2000SE |
| K993515 | Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe…FOZ · Traditional | 02/25/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1149-2014 Class III | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100…The bar code that is printed on the Master Carton label does not correspond to the product code fully… | 02/19/2014Terminated |
| Z-0601-2011 | Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical… | 11/01/2010Terminated |
| Z-0600-2011 | Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical… | 11/01/2010Terminated |
| Z-0599-2011 | Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical… | 11/01/2010Terminated |
| Z-1545-2008 | Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical… | 03/20/2008Terminated |
| Z-1544-2008 | Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical… | 03/20/2008Terminated |
| Z-1543-2008 | Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical… | 03/20/2008Terminated |