Prismaflex System — Class II medical device recall Z-1829-2020
Terminated recall by Baxter Healthcare Corporation, reported 2020-05-06, distributed in PR. Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of c
| Recall number | Z-1829-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-02-06 |
| Classified | 2020-04-30 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2021-06-01 |
| Distributed | PR |
| Quantity | 1,225 units |
| UPC / GTIN / UDI-DI | 07332414105266 |
Product
Prismaflex System, Prismaflex Control Unit
Reason for recall
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
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-1829-2020. 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.