Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the…
Medical device recall Z-0272-2023. Published in FDA’s Enforcement Report on Nov 30, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 30, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 3 states named in where it went
- 422 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
422 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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 2025826 2046165 2046167 2046168 2046169 2046170 2046171 2046172 2046173 2046174 2046175 2046176 2046177 2046178 2046179 2046181 2046182 2046185 2025809 2038684 2033876 2067955 2067957 2067960 2067961 2067963 2067964 2067965 2067966 2067967 2067968 2067969 2067971 2067972 2067973 2067974 2067975 2067976 2067978 2067980 2067981 2067982 2067983 2067984 2067985 2067987 2067989 2067991 2067993 2067994 2067995 2067996 2067997 2067998 2067999 2068000 2068001 2068003 2068007 2068008 2068010 2068011 2068012…
FDA’s list runs to 3,500 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US distribution to states of: Indiana, Texas and Virginia
The states and territories these words name
- Indiana
- Texas
- Virginia
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 10, 2022.
- FDA classified it on Nov 21, 2022.
- FDA’s Enforcement Report published it on Nov 30, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smiths Medical ASD Inc., of Minneapolis, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,500 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.