Plum 360 Infusion System — Class II medical device recall Z-0101-2018
Terminated recall by ICU Medical Inc, reported 2017-11-22, distributed nationwide. (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting fo
| Recall number | Z-0101-2018 |
|---|---|
| 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 | 2017-10-30 |
| Classified | 2017-11-16 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2019-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 21,461 devices |
| Reason classes | device malfunction |
Product
Plum 360 Infusion System, List number 30010.
Reason for recall
(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.
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-0101-2018. 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.