ICU Medical Inc recalls Plum 360 Infusion System, List number 30010.

Recall date

October 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0101-2018

FDA classification

Class II

Brand / firm

ICU Medical Inc

Sold / distributed

Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.

Why it was recalled

(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Plum 360 Infusion System, List number 30010.