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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)
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Top companies in NGT

DateFirm and productCodeLinked 510(k)
Aug 11, 2026Spectra 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
NGTK082689
K103740
Oct 23, 2025Medline Industries, LP
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Open, Classified
NGTK173348
Feb 22, 2024MRP, 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
NGTK113555
Jan 17, 2024Becton Dickinson & Company
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Open, Classified
NGTK161552
Dec 20, 2023Nurse Assist, LLC
0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
Open, Classified
NGTK201286
Dec 20, 2023Nurse 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
NGTK030813
K083042 +1
Aug 26, 2022Mckesson 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
NGTK091583
Aug 17, 2022Family Dollar Stores, Llc.
GS SALINE SOLUTION 12FL OZ, SKU 902274
Open, Classified
NGTNone listed
Mar 4, 2022MEDLINE 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
NGTK082837
Aug 19, 2021Windstone 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
NGTK032438
Aug 4, 2021Cardinal 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
NGTK032438
Aug 4, 2021Cardinal 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
NGTK032438
Aug 4, 2021Cardinal 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
NGTK032438
Apr 16, 2020Becton Dickinson & Company
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Terminated
NGTK153481
Oct 14, 2019Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
Terminated
NGTK161552
Oct 14, 2019Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Terminated
NGTK161552
Feb 1, 2018Medline 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
NGTK142620
Jan 3, 2017Nurse 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
NGTK150143
Sep 1, 2015Covidien 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
NGTNone listed
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTNone listed
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Sep 1, 2015Covidien 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
NGTK060339
Aug 27, 2015MRP, LLC dba AMUSA
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Terminated
NGTK120836
Jun 15, 2015MRP, 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
NGTK120836
Jun 4, 2015MRP, 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
NGTK133685
Sep 22, 2014Becton 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
NGTK121050
Sep 19, 2014Centurion 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
NGTK042061
Feb 20, 2014Merit 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
NGTNone listed
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Sep 10, 2013Covidien 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
NGTK032438
Jan 10, 2013Merit 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
NGTK090882
Sep 15, 2012Amsino 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
NGTK111034
Sep 15, 2012Amsino 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
NGTK111034
Jan 11, 2012Hospira 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
NGTK090882

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