FDA Device recall Z-0084-2023
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640)
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640) by Baxter Healthcare, citing within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information relate….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0084-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-14 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.
Reason
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Identifiers
| code_info | UDI: 07332414075682 (product code 107643), 07332414075613 (product code 107636), 07332414075651 (product code 107640); All Lot Codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0084-2023%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.