FDA Device recall Z-0085-2023
Prismaflex HF20 Set (product code 109841)
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Prismaflex HF20 Set (product code 109841) 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-0085-2023 |
| 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 HF20 Set (product code 109841). 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 07332414089443, 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-0085-2023%22
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