Prismaflex 5 — Class II medical device recall Z-1923-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-05-30, distributed in PR. Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for
| Recall number | Z-1923-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2021-06-22 |
| Distributed | PR |
| Countries outside the US | AR, AU, BB, BD, BM, BR, CA, CL, CN, CO, CR, DO, HK, HT, ID, IN, JP, KR, LK, MX, MY, NZ, PH, SG, TH, TW, VE, VN |
| Quantity | 1,256 units |
| Reason classes | device malfunction, software |
Product
Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Reason for recall
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
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-1923-2018. 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.