Smiths Medical ASD, Inc. is correcting 5 units of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, equipped with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. The company discovered that these specific software versions may cause the pump to continue running past its set volume limit, leading to an over-delivery of medication if the syringe is over-filled. No reports of serious patient injury have been received at the time of this recall. These pumps were distributed in Florida, New York, and Virginia.
The obsolete software fails to stop the pump at the programmed limit, which can cause the device to deliver more medication than intended. This over-delivery of fluids or medication can lead to serious health complications depending on the substance being infused.
Correction of obsolete software versions
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response