Medfusion — Class II medical device recall Z-0314-2018
Terminated recall by Smiths Medical ASD Inc., reported 2018-01-10, distributed nationwide. Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect
| Recall number | Z-0314-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2018-01-04 |
| Reported by FDA | 2018-01-10 |
| Terminated | 2025-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, GB, IN, OM, PA, PH |
| Quantity | 9,787 units |
| NDC | 03500-0600-51 |
| Model numbers | 3500 |
Product
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration 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 the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
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-0314-2018. 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.