Prismaflex Control Unit — Class II medical device recall Z-2066-2020
Terminated recall by Baxter Healthcare Corporation, reported 2020-05-27, distributed in GU, PR. Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
| Recall number | Z-2066-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-04-07 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-11-09 |
| Distributed | GU, PR |
| Quantity | 5 devices |
| Lot numbers | PA18198, PA18199, PA18238, PA22556, PA22558 |
Product
Prismaflex Control Unit
Reason for recall
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
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-2066-2020. 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.