Plum 360 Infusion System — Class II medical device recall Z-3031-2017
Terminated recall by ICU Medical Inc, reported 2017-08-23, distributed nationwide. Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing
| Recall number | Z-3031-2017 |
|---|---|
| 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 | 2017-06-15 |
| Classified | 2017-08-14 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2020-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CL, CO, ES, FR, GB, GR, HK, IE, IT, JO, KW, MX, NZ, OM, PE, PH, PL, SA, TR |
| Quantity | 68,559 units |
| Model numbers | 30010 |
Product
Plum 360 Infusion System
Reason for recall
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.
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-3031-2017. 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.