ClearanceBrief
510(k) K111386 ยท FRN Pump, Infusion

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)

ApplicantSmiths Medical MD, Inc., St. Paul MN, US
DecisionSubstantially Equivalent, Aug 29, 2011
ReceivedMay 18, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K111386

DateFirm and productCodeLinked 510(k)
Apr 15, 2024Smiths 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
FRNNone listed
Apr 15, 2024Smiths Medical ASD Inc.
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Open, Classified
MRZNone listed
Feb 1, 2024Smiths Medical ASD Inc.
smiths medical Medfusion Model 4000 syringe pump
Open, Classified
FRNNone listed
Oct 6, 2023Smiths 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
FRNNone listed
Nov 21, 2022Smiths 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
FRNNone listed
Apr 18, 2022Smiths 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
FRNNone listed
Feb 17, 2022Smiths 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
FRNNone listed
Aug 6, 2020Smiths 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
FRNNone listed
Aug 6, 2020Smiths Medical ASD Inc.
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Open, Classified
FRNNone listed
Dec 12, 2019Smiths 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
FRNNone listed
Oct 15, 2018Smiths 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
LKKNone listed
Apr 13, 2018Smiths Medical ASD Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Terminated
FRNNone listed
Mar 5, 2018Smiths 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
FRNNone listed
Aug 22, 2017Smiths 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
FRNNone listed
Dec 19, 2013Smiths 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
FRNNone listed
Aug 1, 2012Smiths 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
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.