Smiths Medical — Class I medical device recall Z-2107-2012
Terminated recall by Smiths Medical ASD, Inc., reported 2012-08-08, distributed in CA. Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a dev
| Recall number | Z-2107-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2012-02-14 |
| Classified | 2012-08-01 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2012-11-14 |
| Distributed | CA |
| Countries outside the US | CA |
| Reason classes | software |
| NDC | 04000-0100-50, 04000-0100-95, 04000-0101-50, 04000-0101-51, 04000-0101-78 |
| Model numbers | 4000 |
Product
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Reason for recall
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
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-2107-2012. 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.