# FDA recall Z-0764-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2022-11-23.

## Product

Revaclear 400 dialyzers.      Indicated for treatment of chronic and acute renal failure by hemodialysis.

## Reason for recall

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.

## Key facts

- **Recall number:** Z-0764-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-23
- **Report date:** 2022-12-28

- **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-0764-2023

## Citation

> AI Analytics. FDA recall Z-0764-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0764-2023. Source: US FDA. Licensed CC0.

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