Medfusion 4000 Syringe Pump Early Version Software Issues Cause Class I Recall

The FDA has deemed Smiths Medical’s recall of its Medfusion model 4000 syringe pump as Class I for software issues that can make the pump fail and delay or interrupt therapy or fail to deliver therapy according to the programmed setting.

The infusion pump is used to administer fluids such as blood, lipids, drugs, antibiotics, and therapeutic fluids through various delivery routes, including arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral. The 50,743 pumps affected by the recall were distributed between Nov. 16, 2010, and July 28, 2023.

This Class I recall is a correction, not a product removal, and as such, company sent an urgent medical device correction letter to customers advising them to confirm all pumps have the most recent software installed.

Read the FDA’s recall notice here.

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