FDA Device recall Z-0081-2023
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697)
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Prismaflex M Set: M60 (product code 106696), M100 (product code 106697) 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-0081-2023 |
| 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 M Set: M60 (product code 106696), M100 (product code 106697). 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: 07332414064549 (product code 106696), 07332414064556 (product code 106697); 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-0081-2023%22
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