January 7, 2020
FDA: Class I recall of Medfusion 4000 Syringe Pumps
Editor's Note
The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious.
The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy.
The company has received 74 complaints related to the software. No injuries or deaths have been reported.
Distribution dates were September 27, 2019 to October 31, 2019.
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