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ICU Medical is recalling replacement batteries for the Plum 360, Plum A+, and Plum A+3 Infusion Systems because a manufacturing defect has substantially diminished how long they can be used to run the system. If the pump is running on battery power and there is no AC power backup available, the system may shut down an ongoing infusion and power down sooner than expected.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
Customers who need additional information or assistance with this recall may contact USA Medical Technical Assistance team at 1-800-241-4002, option 3.
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