Alaris PCA Module Model 8120 — Class II medical device recall Z-3139-2024
Ongoing recall by CareFusion 303, Inc., reported 2024-09-25, distributed nationwide. Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause
| Recall number | Z-3139-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2024-08-15 |
| Classified | 2024-09-13 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, HU, KW, NZ, QA, SA, SG, TW |
| Quantity | 10,460 |
| UPC / GTIN / UDI-DI | 10885403494291, 10885403515316, 10885403516030, 10885403812002, 10885403812026, 10885403812033 |
| Serial numbers | 16189354, 16189366, 16189371, 16189373, 16189380, 16189384, 16189387, 16189391, 16189394, 16189400, 16189405, 16189408, 16189413, 16189420, 16189424, 16189430, 16189435, 16189440, 16189443, 16189447, 16189451, 16189457, 16189461, 16189469, 16189472 and 475 more |
| Model numbers | 8120 |
Product
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Reason for recall
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
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-3139-2024. 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.