FDA Device recall Z-0171-2020
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010 by Icu Medical, citing A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperabl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0171-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-01 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Reason
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
Identifiers
| code_info | All Plum 360 Infusers with software versions 15.10.00.010/.011/.012 and 15.11.00.017 when used with an ICU Medical MedNet CDL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0171-2020%22
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