Prismaflex Control Unit — Class II medical device recall Z-1279-2021
Terminated recall by Baxter Healthcare Corporation, reported 2021-03-31, distributed nationwide. Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning Syst
| Recall number | Z-1279-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2021-01-28 |
| Classified | 2021-03-19 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2024-06-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HT, HU, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, KY, LB, LT, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 1,650 units |
| UPC / GTIN / UDI-DI | 07332414117702, 07332414124236, 07332414126766 |
| Serial numbers | PA15869, PA15870, PA15871, PA15872, PA15873, PA15874, PA15875, PA15876, PA15877, PA15878, PA15879, PA15880, PA15881, PA15882, PA15883, PA15884, PA15886, PA15887, PA15888, PA15889, PA15890, PA15963, PA15964, PA15965, PA15966 and 475 more |
Product
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Reason for recall
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
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-1279-2021. 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.