Smiths Medical Recalls Medfusion Syringe Infusion Pumps

En Español

On February 14, 2012 Smiths Medical recalled model 4000 of the Medfusion Syringe Infusion Pump. Smiths Medical issued this urgent Class 1 recall after discovering that this particular model of the Medfusion Syringe Infusion Pump contained system errors that result in spontaneous termination of activity. According to reports, the system shifts into “alarm condition” and shuts down completely. The outcome of the situation is a disturbance or interruption in the patients therapy, which for many may cause serious side effects or death.

Which Products Are Involved in the Recall?

Smiths Medical has issued a recall of all Model 4000 Medfusion Syringe Pumps equipped with either Software Version V1.0 or V1.1. Reorder numbers of these products are as follows:

• 4000-0100-50
• 4000-0100-95
• 4000-0101-50
• 4000-0101-51
• 4000-0101-78

Recalled Medfusion Syringe Infusion Pumps were distributed beginning on September 10, 2010 through February 3, 2012.

View a full list of serial numbers of recalled items by visiting the FDA’s recall information page here.

What Should I Do with Recalled Medfusion Syringe Infusion Pumps?

Smiths Medical has informed customers that restoration of Medfusion Syringe Infusion Pumps calls for an upgrade in the system’s software. For questions or concerns, call Smiths Medical Customer Support at 1-800-258-5361.

The U.S. Food and Drug Administration has not received any reports of adverse reactions. If you experience any serious side effects caused by the recalled Medfusion Syringe Infusion Pumps, contact the FDA MedWatch Adverse Event Reporting Program or get help by filling in the contact form to the left of the page.