Replacement Battery List Number SUB0000864 — Class I medical device recall Z-2447-2024
Ongoing recall by ICU Medical Inc, reported 2024-08-21, distributed nationwide. Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity
| Recall number | Z-2447-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2024-05-07 |
| Classified | 2024-08-09 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, ES, FR, GB, GT, IE, IT, OM, PY, QA, SA, TR, TW, UY, ZA |
| Quantity | 11,961 units |
| UPC / GTIN / UDI-DI | 03353001004131, 03353001088131 |
| Serial numbers | 19986061, 19986186, 19986352, 19987383, 19987470, 19987546, 19987612, 19989077, 19989189, 19990056, 19990425, 19993393, 19993504, 19993655, 19993728, 19993852, 19993975, 19994051, 19994204, 19994871, 19994923, 19995079, 19995138, 19995161, 19997579 and 475 more |
Product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet
Reason for recall
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
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-2447-2024. 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.