# FDA recall Z-0083-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2022-09-14.

## 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.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0083-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-14
- **Report date:** 2022-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2023

## Citation

> AI Analytics. FDA recall Z-0083-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0083-2023. Source: US FDA. Licensed CC0.

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