ICU Medical Plum Infusion System Battery Recall Deemed Class I by FDA

ICU Medical’s recall of replacement batteries for several of its infusion systems has been deemed a Class I recall by the FDA, the most serious type of recall because use of the devices may cause serious injury or death.

The recall affects 1,904 replacement batteries for the Plum 360, Plum A+ and Plum A+3 large volume infusion pumps to deliver blood or blood products, drugs, and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration. The system uses batteries when the pump is not plugged into AC power, for example when a patient is being transported.

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, which may cause serious injury or death to patients due to interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications.

The company initially recalled the batteries March 22 because of a potential manufacturing defect that can substantially diminish the battery’s length of charge. ICU Medical has received 54 complaints about the issue, but no reports of injury or death.

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