FDA Device recall Z-0280-2020
Prismaflex Control Unit, software versions below 7.21
- FDA Device
- Class II
- ongoing
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Prismaflex Control Unit, software versions below 7.21 by Baxter Healthcare, citing communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0280-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-04 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Prismaflex Control Unit, software versions below 7.21
Reason
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Identifiers
| code_info | Product Code: 6023014700; All Lot numbers; GTIN: 07332414073718. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0280-2020%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.