Prismaflex Control Unit — Class II medical device recall Z-1280-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-04-11, distributed nationwide. Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe
| Recall number | Z-1280-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2017-02-15 |
| Classified | 2018-03-30 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BG, BH, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DO, DZ, EE, EG, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IS, IT, JO, KE, KR, KW, LB, LT, LV, MA, MT, MY, NG, NL, NO, NZ, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 3,440 units |
| Reason classes | software |
Product
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. 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.
Reason for recall
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
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-1280-2018. 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.