Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module — Class II medical device recall Z-0171-2020
Terminated recall by ICU Medical Inc, reported 2019-10-30, distributed nationwide. A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is dow
| Recall number | Z-0171-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2019-10-22 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 47,152 devices |
| Reason classes | device malfunction, software |
| Model numbers | 30010 |
Product
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0171-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.