Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe… — Class II medical device recall Z-0540-2014
Terminated recall by Smiths Medical ASD, Inc., reported 2013-12-25, distributed nationwide. Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has
| Recall number | Z-0540-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2013-11-22 |
| Classified | 2013-12-19 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2015-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, SA |
Product
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
Reason for recall
Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC po
Machine access
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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.