Panels › General Hospital › Product code NGT · Class 2
Saline, Vascular Access Flush
Regulation 880.5200
1510(k)s in 12 months (40 all time)
1recalls in 12 months (61 all time)
56recalls that name a 510(k)
Top companies in NGT
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LLC | 0 | 28 |
| Becton Dickinson | 2 | 5 |
| Excelsior Medical Corp. | 3 | 3 |
| Becton, Dickinson and Company | 5 | 0 |
| Nurse Assist, Inc. | 2 | 3 |
| Am USA | 4 | 0 |
| Medefil, Inc. | 4 | 0 |
| Medline Industries, Inc. | 2 | 2 |
| Medxl, Inc. | 4 | 0 |
| Cardinal Health | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2026 | Spectra Medical Devices, Llc Brand Name: Elevaris/Spectra Medical Devices
Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule
Model/Catalog Number: AMPUL10MLK.
Sodium Chloride Flush for IV tubing systems and indwel Open, Classified |
NGT | K082689 K103740 |
| Oct 23, 2025 | Medline Industries, LP Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes Open, Classified |
NGT | K173348 |
| Feb 22, 2024 | MRP, LLC dba Aquabiliti AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syrin Open, Classified |
NGT | K113555 |
| Jan 17, 2024 | Becton Dickinson & Company PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547 Open, Classified |
NGT | K161552 |
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 Open, Classified |
NGT | K201286 |
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-B Open, Classified |
NGT | K030813 K083042 +1 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130.
b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/C Open, Classified |
NGT | K091583 |
| Aug 17, 2022 | Family Dollar Stores, Llc. GS SALINE SOLUTION 12FL OZ, SKU 902274 Open, Classified |
NGT | None listed |
| Mar 4, 2022 | MEDLINE INDUSTRIES, LP - Northfield Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/po Terminated |
NGT | K082837 |
| Aug 19, 2021 | Windstone Medical Packaging, Inc. Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following
Aligned Medical Solutions Custom Convenience Kits:
AMS-9041CP Leaderflex Insertion Kit with Ultras Open, Classified |
NGT | K032438 |
| Aug 4, 2021 | Cardinal Health Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125
The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intr Open, Classified |
NGT | K032438 |
| Aug 4, 2021 | Cardinal Health Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123
The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling int Open, Classified |
NGT | K032438 |
| Aug 4, 2021 | Cardinal Health Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121
The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling in Open, Classified |
NGT | K032438 |
| Apr 16, 2020 | Becton Dickinson & Company BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535 Terminated |
NGT | K153481 |
| Oct 14, 2019 | Becton Dickinson & Company BD Posiflush Pre-Filled Normal Saline Syringes
Catalog Number: 306575 (Canada only) Terminated |
NGT | K161552 |
| Oct 14, 2019 | Becton Dickinson & Company BD Posiflush Pre-Filled Normal Saline Syringes
Catalog Number: 306547 Terminated |
NGT | K161552 |
| Feb 1, 2018 | Medline Industries Inc Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR
Intended for flushing IV catheters and IV tubing only. Terminated |
NGT | K142620 |
| Jan 3, 2017 | Nurse Assist, Inc Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP
Product usage: Saline flush Terminated |
NGT | K150143 |
| Sep 1, 2015 | Covidien LLC MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray
Item Code: 8888104003HP
Product Usage:
Sterile Delivery are indicated for use in flushing com Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray
Item Code: 8888103003HP
Product Usage:
Sterile Delivery are indicated for use in flushing comp Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray
Item Code: 8888103002HP
Product Usage:
Sterile Delivery are indicated for use in flushing compatib Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm
Item Code: 8888233420
Product Usage:
Sterile Delivery are indicated for use in flushing Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm
Item Code: 8888233413
Product Usage:
Sterile Delivery are indicated for use in flushing Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm
Item Code: 8888222420
Product Usage:
Sterile Delivery are indicated for use in flushing co Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm
Item Code: 8888222416
Product Usage:
Sterile Delivery are indicated for use in flushing com Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm
Item Code:8888221420
Product Usage:
Sterile Delivery are indicated for use in flushing co Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm
Item Code: 8888213420
Product Usage:
Sterile Delivery are indicated for use in flushin Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm
Item Code: 8888211424
Product Usage:
Sterile Delivery are indicated for use Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm
Item Code: 8888135139
Product Usage:
Sterile Delivery are indicated for use in flushing com Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm
Item Code: 8888135137
Product Usage:
Sterile Delivery are indicated for use in fl Terminated |
NGT | K060339 |
| Sep 1, 2015 | Covidien LLC Monoject 0.9% Saline Flush Prefill Double Pouch
Item Code: 8881570129
Product Usage:
Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intrav Terminated |
NGT | K060339 |
| Aug 27, 2015 | MRP, LLC dba AMUSA 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. Terminated |
NGT | K120836 |
| Jun 15, 2015 | MRP, LLC dba AMUSA T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706
Usage: Flush syringe. Terminated |
NGT | K120836 |
| Jun 4, 2015 | MRP, LLC dba AMUSA 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806
Usage: Flush syringe. Terminated |
NGT | K133685 |
| Sep 22, 2014 | Becton Dickinson & Company BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553.
Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Sal Terminated |
NGT | K121050 |
| Sep 19, 2014 | Centurion Medical Products Corporation 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. Terminated |
NGT | K042061 |
| Feb 20, 2014 | Merit Medical Systems, Inc. Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices Terminated |
NGT | None listed |
| Sep 10, 2013 | Covidien LLC Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill
Product ID: 8881590125
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syring Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill
Product ID: 8881590123
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringe Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill
Product ID: 8881590121
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syring Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill
Product ID: 8881580125
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill
Product ID: 8881580123
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill
Product ID:8881580121
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill
Product ID: 8881570125
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syri Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill
Product ID: 8881570123
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syri Terminated |
NGT | K032438 |
| Sep 10, 2013 | Covidien LLC Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill
Product ID: 8881570121
Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syr Terminated |
NGT | K032438 |
| Jan 10, 2013 | Merit Medical Systems, Inc. Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the conv Terminated |
NGT | K090882 |
| Sep 15, 2012 | Amsino Medical USA 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60 Terminated |
NGT | K111034 |
| Sep 15, 2012 | Amsino Medical USA 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 600 Terminated |
NGT | K111034 |
| Jan 11, 2012 | Hospira Inc. 0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; Made in Co Terminated |
NGT | K090882 |
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