FDA Device recall Z-0272-2023

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP)…

FDA Device
Class II
ongoing
Published 2022-11-30

On 2022-11-30 the FDA classified a Class II recall of Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP)… by Smiths Medical Asd, citing potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0272-2023
Classification	Class II
Status	ongoing
Initiated	2022-10-10
Published	2022-11-30
Last updated	2026-09-13 11:56 UTC
Company	Smiths Medical Asd
Distribution	IN, TX, VA

Product

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 infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

Reason

Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

Identifiers

code_info	Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962; Serial #'s 2033844 2033845 2033846… Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962; Serial #'s 2033844 2033845 2033846 2033850 2033851 2033852 2033854 2033856 2033857 2033858 2033859 2033861 2033862 2033864 2033865 2033866 2033867 2033871 2033875 2033877 2033878 2033880 2033982 2033984 2034104 2034106 2034107 2034108 2034109 2034110 2034113 2034115 2034116 2034117 2034118 2034120 2034123 2034124 2034125 2034126 2034129 2034131 2034132 2034133 2034134 2034135 2034136 2034137 2034138 2034139 2034140 2034141 2034142 2034143 2034144 2034145 2034146 2034147 2034148 2034149 2034150 2034151 2034152 2034153 2034154 2034155 2034201 2034202 2034204 2034205 2034222 2034223 2034224 2034225 2035182 2035183 2035184 2035185 2035186 2035187 2035188 2035190 2035191 2035193 2035194 2035195 2035196 2035197 2035198 2035200 2035201 2035202 2035203 2035204 2035205 2035206 2035207 2035209 2035210 2035212 2035214 2035216 2035217 2035218 2035811 2035812 2035813 2035814 2035815 2035816 2035817 2035819 2035820 2

code_info

Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962; Serial #'s 2033844 2033845 2033846…

Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962; Serial #'s 2033844 2033845 2033846 2033850 2033851 2033852 2033854 2033856 2033857 2033858 2033859 2033861 2033862 2033864 2033865 2033866 2033867 2033871 2033875 2033877 2033878 2033880 2033982 2033984 2034104 2034106 2034107 2034108 2034109 2034110 2034113 2034115 2034116 2034117 2034118 2034120 2034123 2034124 2034125 2034126 2034129 2034131 2034132 2034133 2034134 2034135 2034136 2034137 2034138 2034139 2034140 2034141 2034142 2034143 2034144 2034145 2034146 2034147 2034148 2034149 2034150 2034151 2034152 2034153 2034154 2034155 2034201 2034202 2034204 2034205 2034222 2034223 2034224 2034225 2035182 2035183 2035184 2035185 2035186 2035187 2035188 2035190 2035191 2035193 2035194 2035195 2035196 2035197 2035198 2035200 2035201 2035202 2035203 2035204 2035205 2035206 2035207 2035209 2035210 2035212 2035214 2035216 2035217 2035218 2035811 2035812 2035813 2035814 2035815 2035816 2035817 2035819 2035820 2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0272-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.