FDA Device recall Z-0101-2018
Plum 360 Infusion System, List number 30010
- FDA Device
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of Plum 360 Infusion System, List number 30010 by Icu Medical, citing (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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0101-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-30 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Plum 360 Infusion System, List number 30010.
Reason
(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.
Identifiers
| code_info | All devices with software v15.10.00.010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0101-2018%22
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