Heparin, Vascular Access Flush
FDA product code NZW · Class II (moderate risk) · 21 CFR 880.5200 · General Hospital
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
7510(k) clearances
0PMA approvals
44recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush SyringeNZW · Special | Becton, Dickinson and Company | 02/27/2017SE |
| K133446 | Heparin Lock / Flush SyringesNZW · Traditional | Excelsior Medical Corporation | 11/14/2014SE |
| K092938 | Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710NZW · Traditional | App Pharmaceuticals, LLC | 06/18/2010SE |
| K092491 | Medefil's Heparin I.V. Flush Syringe 1 Unit/Ml; 10 Units/Ml; and 100 Units/Ml in Various…NZW · Traditional | Medefil, Inc. | 02/03/2010SE |
| K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeNZW · Special | Becton, Dickinson & CO | 06/10/2009SE |
| K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/MlNZW · Traditional | Excelsior Medical Corp. | 02/23/2007SE |
| K023740 | Syrex Pre-Filled SyringeNZW · Traditional | Excelsior Medical Corp. | 05/13/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1596-2022 Class II | Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1989-2016 Class II | Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL…Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay… | Excelsior Medical Corp | 04/28/2016Terminated |
| Z-1032-2015 Class II | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per…The lot failed pH specification. | Fresenius Kabi USA, LLC | 12/19/2014Terminated |
| 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… | Medefil Incorporated | 02/19/2014Terminated |
| Z-1808-2012 Class II | Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1807-2012 Class II | Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1806-2012 Class II | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1805-2012 Class II | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1804-2012 Class II | Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1803-2012 Class II | Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1802-2012 Class II | Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1801-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1800-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1799-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1798-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1797-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | Vygon Corporation | 05/11/2012Terminated |
| Z-1707-2012 | Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush…Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL… | Excelsior Medical Corp | 05/07/2012Terminated |
| 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… | Medefil Incorporated | 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… | Medefil Incorporated | 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… | Medefil Incorporated | 11/01/2010Terminated |
| Z-1825-2012 Class II | HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic…CGMP Deviations: Incomplete documentation associated with test results. | App Pharmaceuticals Llc | 05/20/2010Terminated |
| Z-1824-2012 Class II | HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic…CGMP Deviations: Incomplete documentation associated with test results. | App Pharmaceuticals Llc | 05/20/2010Terminated |
| Z-1602-2008 | Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1601-2008 | Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1600-2008 | Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF #…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1599-2008 | Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF #…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1598-2008 | Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1597-2008 | Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1596-2008 | Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1595-2008 | Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| Z-1594-2008 | Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF #…Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical… | Covidien LP | 03/28/2008Terminated |
| 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… | Medefil Incorporated | 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… | Medefil Incorporated | 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… | Medefil Incorporated | 03/20/2008Terminated |
| Z-1393-2008 | Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1392-2008 | Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1391-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1390-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1389-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1388-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1387-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1386-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1385-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |
| Z-1384-2008 | Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC…Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which… | Baxter Healthcare Corp. | 02/28/2008Terminated |