The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious.
The recall was initiated because a manufacturing defect substantially diminished how long the batteries can be used to run the system.
The company has received 54 Plum 360 and 465 Plum A+/A+3 complaints, and no injuries or deaths have been reported. The FDA has identified an adverse event that may be related to the issue.
Distribution dates were February 7, 2022, to December 22, 2022.
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