Prismaflex Control Unit — Class II medical device recall Z-0278-2020
Ongoing recall by Baxter Healthcare Corporation, reported 2019-11-13, distributed nationwide. Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-r
| Recall number | Z-0278-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-10-04 |
| Classified | 2019-11-04 |
| Reported by FDA | 2019-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BB, BD, CA, CN, CR, DO, HT, ID, IN, JP, KR, MY, NZ, SG, TH, TW, VE, VN |
| Quantity | 988 units |
| UPC / GTIN / UDI-DI | 07332414115395 |
Product
Prismaflex Control Unit, software versions below 7.21
Reason for recall
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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-0278-2020. 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.