Smiths Medical Recalls Instructions for Using Three Infusion Pumps (SNF/AL)

The U.S. Food and Drug Administration (FDA) sent a bulletin announcing that Smiths Medical sent three letters to affected customers with corrected use instructions for certain CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps. The recall of instructions impacts the Infusion Pump False Occlusion Alarm, Infusion Pump Thermal Damage Issue, and Infusion Pump Intermittent Connection Issue. 

Please note: The recall involves updating instructions for using the devices. The recall does not involve removing the pumps from where they are used or sold. Potential health consequences of not using the new instructions include interruptions or delays of therapy, which can lead to serious patient injury or death depending on the clinical situation and the type of medication being administered. Smiths Medical has not reported any serious injuries or deaths associated with these issues. 

Health care professionals may report adverse reactions or quality problems they experience with these devices to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program.