# FDA recall Z-0760-2023

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

## Product

Revaclear 400 Dialyzer. Product Code: 114746L.    Used to treat chronic and acute renal failure by hemodialysis.

## Reason for recall

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

## Distribution

Worldwide distribution.  US Nationwide including Guam and St. Thomas USVI; 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, and Trinidad and Tobago.

## Key facts

- **Recall number:** Z-0760-2023
- **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-0760-2023

## Citation

> AI Analytics. FDA recall Z-0760-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0760-2023. Source: US FDA. Licensed CC0.

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