FDA Device recall Z-2066-2020
Prismaflex Control Unit
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Prismaflex Control Unit by Baxter Healthcare, citing prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2066-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-07 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | PR |
Product
Prismaflex Control Unit
Reason
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Identifiers
| code_info | Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2066-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.