Medfusion Model 4000 Syringe Infusion Pump — Class II medical device recall Z-0272-2023
Ongoing recall by Smiths Medical ASD Inc., reported 2022-11-30, distributed in IN, TX, VA. Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which m
| Recall number | Z-0272-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2022-10-10 |
| Classified | 2022-11-21 |
| Reported by FDA | 2022-11-30 |
| Distributed | IN, TX, VA |
| Quantity | 422 devices |
| NDC | 04000-0106-00, 04000-0106-01 |
| Serial numbers | 2006685, 2006717, 2006750, 2008582, 2008620, 2020917, 2025796, 2025806, 2025809, 2025812, 2025826, 2028673, 2032957, 2033844, 2033845, 2033846, 2033847, 2033848, 2033849, 2033850, 2033851, 2033852, 2033853, 2033854, 2033855 and 397 more |
| Model numbers | 4000 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0272-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.