Medfusion Syringe Pump Model 3500 — Class I medical device recall Z-2735-2020
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-2735-2020 |
|---|---|
| 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 | 17,019 units |
| NDC | 03500-0600-00, 03500-0600-01, 03500-0600-50, 03500-0600-51, 03500-0600-82 |
| Model numbers | 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82 |
Product
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
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-2735-2020. 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.