510(k) K111386 ยท FRN Pump, Infusion
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
| Applicant | Smiths Medical MD, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 29, 2011 |
| Received | May 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers:
a) 4000-0101-249,
b) 4000-0101-50,
c) 4000-0101-51,
d) 4000-0105-249,
e) 4000-0105-50,
f) 4000-0105-51,
g) 4000-0105-78,
h) 400 Open, Classified |
FRN | None listed |
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 Open, Classified |
MRZ | None listed |
| Feb 1, 2024 | Smiths Medical ASD Inc. smiths medical Medfusion Model 4000 syringe pump Open, Classified |
FRN | None listed |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 4000-XXXX-XX:
a) 0100-50,
b) 0100-249,
c) 0101-50,
d) 0101-51,
e) 0101-78,
f) 0101-249,
g) 0105-51,
h) 0105-78,
i) 0105-249,
j) 0106-00,
k) 0106-01,
l) 0106-23 Open, Classified |
FRN | None listed |
| Nov 21, 2022 | Smiths Medical ASD Inc. Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment.
Used for infusi Open, Classified |
FRN | None listed |
| Apr 18, 2022 | Smiths Medical ASD Inc. Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4 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 |
| Dec 12, 2019 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient Terminated |
FRN | None listed |
| Oct 15, 2018 | Smiths Medical ASD Inc. Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS).
Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2;
MEDFUSION 400 Terminated |
LKK | 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 4000 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 V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK.
In the administration of f Terminated |
FRN | None listed |
| Dec 19, 2013 | Smiths Medical ASD, Inc. Medfusion 4000 Syringe Infusion Pumps
Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pu Terminated |
FRN | None listed |
| Aug 1, 2012 | Smiths Medical ASD, Inc. Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.
Designed for use Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.