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 envi

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US distribution to states of: Indiana, Texas and Virginia Quantity: 422 devices Lot/code info: 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 2035821 2035826 2035827 2035828 2035829 2035830 2035832 2035851 2035852 2035853 2035854 2037161 2033881 2033981 2038674 2038675 2038676 2038677 2038678 2038679 2038680 2038681 2038683 2038685 2038686 2038687 2038688 2038689 2038690 2038691 2038692 2038693 2038694 2038695 2038696 2035850 2034112 2034114 2034121 2035818 2033855 2034119 2035189 2035211 2033849 2035192 2035199 2035208 2035809 2035822 2035824 2035810 2035808 2035825 2035823 2035831 2038682 2033872 2033869 2033874 2033860 2025796 20258

UPC codes

501951706962, 501951707075

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.