Class II — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed. |
| Product | Prismaflex Control Unit |
| Quantity | 5 devices US territories |
| Distribution | Distribution only to Puerto Rico and Guam |
| Initiated | 2020-04-07 |
| Classified | 2020-05-21 |
| Terminated | 2021-11-09 |
| Recall number | Z-2066-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corporation (Z-2066-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85405/
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