510(k) K040899 ยท FRN Pump, Infusion
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
| Applicant | Medex, Inc., Dublin OH, US |
| Decision | Substantially Equivalent, Apr 30, 2004 |
| Received | Apr 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers:
a) 3500
b) 3500-0600-00
c) 3500-0600-01
d) 3500-0600-249
e) 3500-0600-50
f) 3500-0600-51
g) 3500-0600-82
h) 3500-306
i) 3500-402
j) 3 Open, Classified |
FRN | None listed |
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Model 3010 Syringe pumps:
a. Protege Model 3010,
b. Medfusion Model 3010A,
c. Protege UK Model 3010E Open, Classified |
FRN | None listed |
| Feb 1, 2024 | Smiths Medical ASD Inc. smiths medical Medfusion Model 3500 Syringe pump Open, Classified |
FRN | None listed |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 Open, Classified |
FRN | None listed |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 Open, Classified |
FRN | None listed |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 3500-0600-XX:
a) 0600-00;
b) 0600-01;
c) 0600-50;
d) 0600-51;
e) 0600-82;
f) 0600-249;
software versions: v3, v4, v5, and v6 Open, Classified |
FRN | None listed |
| Apr 18, 2022 | Smiths Medical ASD Inc. Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500S Open, Classified |
FRN | None listed |
| Feb 17, 2022 | Smiths Medical ASD Inc. Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main Open, Classified |
FRN | None listed |
| Aug 6, 2020 | Smiths Medical ASD Inc. Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 Open, Classified |
FRN | None listed |
| Aug 6, 2020 | Smiths Medical ASD Inc. Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. Open, Classified |
FRN | None listed |
| Apr 13, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism Terminated |
FRN | None listed |
| Mar 5, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Pump 3500 Series
The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood Terminated |
FRN | None listed |
| Mar 5, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Pump 3010 Series
The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood Terminated |
FRN | None listed |
| Aug 22, 2017 | Smiths Medical ASD Inc. Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK.
In the administration of Terminated |
FRN | None listed |
| Mar 26, 2013 | Smiths Medical ASD, Inc. Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500.
Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Terminated |
FRN | None listed |
| Mar 14, 2012 | Smiths Medical ASD, Inc. Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only.
These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood o Terminated |
FRN | None listed |
| Aug 2, 2010 | Smiths Medical ASD, Inc. MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administrati Terminated |
FRN | None listed |
| Jan 15, 2010 | Smiths Medical ASD, Inc. Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA). Terminated |
FRN | None listed |
| Jan 15, 2010 | Smiths Medical ASD, Inc. Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA) Terminated |
FRN | None listed |
| Mar 9, 2009 | Smiths Medical MD, Inc. Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump.
The Medfusion 3500 syringe pump is indicated for use w Terminated |
FRN | None listed |
| Mar 9, 2009 | Smiths Medical MD, Inc. Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable syringe infusion pump.
The Medfusion 3500 syringe pump is indicated for use w Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.