Prismaflex HF Set: HF1000 — Class II medical device recall Z-0083-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2022-10-19, distributed nationwide. Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti
| Recall number | Z-0083-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-09-14 |
| Classified | 2022-10-12 |
| Reported by FDA | 2022-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 328,300 devices |
| UPC / GTIN / UDI-DI | 07332414069254, 07332414069315 |
Product
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0083-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.