Saline, Vascular Access Flush
FDA product code NGT · 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.
40510(k) clearances
0PMA approvals
61recalls
Manufacturers
- Becton, Dickinson and Company 5
- Medefil, Inc. 4
- Medxl, Inc. 4
- Am USA 4
- Excelsior Medical Corp. 3
- Spectra Medical Devices, Inc. 2
- Becton Dickinson & Co. 2
- Nurse Assist, Inc 2
- Medline Industries, LP 2
- Amsino International, Inc. 2
- Tyco Healthcare/Kendall 1
- Hospira Inc. 1
- Ind Ndiagnostic, Inc. 1
- Tyco Healthcare 1
- Kendall 1
- Pentaferte Italia S.R.L. 1
- Anhui Tianyang Pharmaceutical Co., Ltd. 1
- Anhui Tiankang Medical Technology Co., Ltd. 1
- Hantech Medical Device Co., Ltd. 1
- Spm Medicare Pvt. , Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP SyringeNGT · Traditional | Becton, Dickinson and Company | 12/02/2025SE |
| K233623 | Praxiject SP 0.9% NaClNGT · Traditional | Medxl, Inc. | 02/27/2024SE |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution)NGT · Traditional | Spm Medicare Pvt. , Ltd. | 11/09/2023SE |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)NGT · Traditional | Hantech Medical Device Co., Ltd. | 09/27/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/12/2023SE |
| K223584 | Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tianyang Pharmaceutical Co., Ltd. | 08/12/2023SE |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush SyringeNGT · Traditional | Becton, Dickinson and Company | 07/21/2023SE |
| K231754 | Praxiject 0.9% NaClNGT · Special | Medxl, Inc. | 07/13/2023SE |
| K214080 | PentaflushNGT · Traditional | Pentaferte Italia S.R.L. | 07/20/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Amsino International, Inc. | 03/22/2022SE |
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9%…NGT · Traditional | Nurse Assist, LLC | 08/11/2020SE |
| K192414 | Praxiject 0.9% NaClNGT · Special | Medxl, Inc. | 02/13/2020SE |
| K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeNGT · Traditional | Medline Industries, Inc. | 09/15/2019SE |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Amsino International, Inc. | 07/12/2019SE |
| K173348 | 0.9% Sodium Chloride Injection, USPNGT · Traditional | Medline Industries, Inc. | 06/21/2018SE |
| K171109 | Praxiject 0.9% NaClNGT · Traditional | Medxl, Inc. | 12/21/2017SE |
| K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeNGT · Special | Becton, Dickinson and Company | 02/02/2017SE |
| K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeNGT · Traditional | Becton, Dickinson and Company | 04/04/2016SE |
| K150143 | Normal Saline FlushNGT · Traditional | Nurse Assist, Inc. | 08/31/2015SE |
| K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride…NGT · Traditional | Excelsior Medical Corporation | 12/12/2014SE |
| K133685 | 0.9% Sodium Chloride Flush SyringeNGT · Traditional | Am USA | 08/13/2014SE |
| K141311 | 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF SyringeNGT · Special | Becton, Dickinson and Company | 07/25/2014SE |
| K121050 | 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush SyringeNGT · Traditional | Becton, Dickinson & CO | 02/07/2013SE |
| K121262 | Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyNGT · Special | Medefil, Inc. | 09/20/2012SE |
| K121231 | Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home TestNGT · Traditional | Ind Ndiagnostic, Inc. | 07/30/2012SE |
| K120836 | 0.9% Sodium Chloride Flish SyringeNGT · Special | Am USA | 07/12/2012SE |
| K113555 | Am USA 0.9% Sodium Chloride Flush SyringeNGT · Special | Am USA | 01/30/2012SE |
| K103740 | Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleNGT · Traditional | Spectra Medical Devices, Inc. | 07/29/2011SE |
| K111034 | Am USA 0.9% Sodium Chloride Flush SyringeNGT · Special | Am USA | 07/14/2011SE |
| K101270 | Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311NGT · Traditional | Excelsior Medical Corp. | 02/10/2011SE |
| K090882 | Flush Syringe Filled with 0.9% Sodium ChlorideNGT · Traditional | Hospira, Inc. | 04/23/2010SE |
| K091583 | Medefil's Normal Saline I.V. Flush SyringeNGT · Special | Medefil, Inc. | 01/28/2010SE |
| K082689 | Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleNGT · Traditional | Spectra Medical Devices, Inc. | 03/20/2009SE |
| K082837 | Sterile Field Saline Pre-Filled Syringe(S)NGT · Special | Excelsior Medical Corp. | 12/18/2008SE |
| K060339 | Kendall Monoject Pre-Fill Advanced 0.9%SODIUM Chloride Flush Syringes for Sterile DeliveryNGT · Special | Tyco Healthcare/Kendall | 04/28/2006SE |
| K042061 | 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush SyringeNGT · Special | Becton Dickinson | 08/26/2004SE |
| K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…NGT · Traditional | Tyco Healthcare | 06/30/2004SE |
| K020996 | Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…NGT · Traditional | Medefil, Inc. | 06/24/2002SE |
| K020999 | Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…NGT · Traditional | Medefil, Inc. | 06/20/2002SE |
| K011283 | Monoject Prefill 0.9% Sodium Chloride Flush SyringeNGT · Traditional | The Kendall Company | 10/15/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2873-2026 Class I | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection…Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the… | Spectra Medical Devices, Llc | 07/06/2026Open, Classified |
| Z-0234-2026 Class II | Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number…Medline has identified a limited quantity of saline IV flush syringes that may not meet the required… | Medline Industries, LP | 09/11/2025Open, Classified |
| Z-1174-2024 Class II | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF…The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months. | MRP, LLC dba Aquabiliti | 12/28/2023Open, Classified |
| Z-0736-2024 Class II | PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with…An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General… | Becton Dickinson & Company | 11/16/2023Open, Classified |
| Z-0512-2024 Class I | 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have… | Nurse Assist, LLC | 11/06/2023Open, Classified |
| Z-0511-2024 Class I | 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL…Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have… | Nurse Assist, LLC | 11/06/2023Open, Classified |
| Z-1543-2022 Class II | GS SALINE SOLUTION 12FL OZ, SKU 902274Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1619-2022 Class II | a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0898-2022 Class II | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection…Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a… | MEDLINE INDUSTRIES, LP - Northfield | 03/04/2022Terminated |
| Z-0119-2022 Class I | Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside…Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential… | Windstone Medical Packaging, Inc. | 08/19/2021Open, Classified |
| Z-2286-2021 Class I | Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125…Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the… | Cardinal Health | 08/04/2021Open, Classified |
| Z-2285-2021 Class I | Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123…Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the… | Cardinal Health | 08/04/2021Open, Classified |
| Z-2284-2021 Class I | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code…Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the… | Cardinal Health | 08/04/2021Open, Classified |
| Z-2065-2020 Class II | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and… | Becton Dickinson & Company | 04/16/2020Terminated |
| Z-0500-2020 Class II | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with… | Becton Dickinson & Company | 10/14/2019Terminated |
| Z-0499-2020 Class II | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with… | Becton Dickinson & Company | 10/14/2019Terminated |
| Z-2948-2018 Class II | Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for…Packaged with an incorrect overwrap. | Medline Industries Inc | 02/01/2018Terminated |
| Z-0926-2017 Class I | Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and…Potential contamination with B. cepacia. | Nurse Assist, Inc | 10/04/2016Terminated |
| Z-2537-2015 Class II | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2536-2015 Class II | MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2535-2015 Class II | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2534-2015 Class II | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2533-2015 Class II | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2532-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2531-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2530-2015 Class II | Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2529-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2528-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC*…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2527-2015 Class II | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2526-2015 Class II | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2525-2015 Class II | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage:…Sterility may be compromised | Covidien LLC | 08/06/2015Terminated |
| Z-2476-2015 Class II | 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.Procedures for the acceptance and control of in-process product have not been adequately established. | MRP, LLC dba AMUSA | 07/02/2015Terminated |
| Z-1709-2015 Class II | 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only…Incorrect expiration date on label | MRP, LLC dba AMUSA | 04/27/2015Terminated |
| Z-1808-2015 Class II | T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12…Incorrect labeling of the expiration date | MRP, LLC dba AMUSA | 02/09/2015Terminated |
| Z-2670-2014 Class II | 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL…Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. | Centurion Medical Products Corporation | 07/25/2014Terminated |
| Z-2673-2014 Class II | BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF…BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553). | Becton Dickinson & Company | 07/22/2014Terminated |
| Z-0980-2014 Class I | Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection…Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed… | Merit Medical Systems, Inc. | 09/30/2013Terminated |
| Z-2186-2013 Class II | Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2185-2013 Class II | Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2184-2013 Class II | Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2183-2013 Class II | Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2182-2013 Class II | Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2181-2013 Class II | Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2180-2013 Class II | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2179-2013 Class II | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-2178-2013 Class II | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Covidien LLC | 08/16/2013Terminated |
| Z-0663-2013 Class II | Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom…Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one… | Merit Medical Systems, Inc. | 09/14/2012Terminated |
| Z-2394-2012 Class III | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single…One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush… | Amsino Medical USA | 08/15/2012Terminated |
| Z-2393-2012 Class III | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use…One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush… | Amsino Medical USA | 08/15/2012Terminated |
| Z-0596-2012 | 0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only…There is particulate matter in the fluid pathway, which has been identified as the same material as the… | Hospira Inc. | 11/18/2011Terminated |