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Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery
ICU Medical is updating the use instructions for the Plum 360, Plum A+ and Plum A+3 Infusion Systems due to a manufacturing defect of the batteries, which can result in the life of the battery to substantially diminish. 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 with no alarm.
This updated notice expands affected products from a March 2023 notice and now includes all replacement batteries manufactured by CSB.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. should report adverse events or product complaints to Global Complaint Management: 1-844-654-7780 or ProductComplaintsPP@icumed.com. For additional information or other assistance, contact Technical Assistance, 1-800-241-4002, option 3.
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