Medfusion Syringe Pump Model 4000 — Class I medical device recall Z-2734-2020
Ongoing recall by Smiths Medical ASD Inc., reported 2020-08-12. Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events
| Recall number | Z-2734-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2020-06-26 |
| Classified | 2020-08-06 |
| Reported by FDA | 2020-08-12 |
| Countries outside the US | AE, AF, AU, BE, BM, CA, CN, DE, DK, GB, HK, ID, IE, IN, KR, KW, LB, MX, MY, NZ, OM, PA, PH, PK, PL, SA, TT |
| Quantity | 35,616 units |
| NDC | 04000-0105-50, 04000-0105-51, 04000-0105-78, 04000-0106-00, 04000-0106-01 |
| Model numbers | 4000, 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, 4000-0106-231 |
Product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Reason for recall
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
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-2734-2020. 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.