FDA Device recall Z-3031-2017
Plum 360 Infusion System
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of Plum 360 Infusion System by Icu Medical, citing potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3031-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-15 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Plum 360 Infusion System
Reason
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Identifiers
| code_info | Model No. 30010 |
|---|
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-3031-2017%22
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