# FDA recall Z-1908-2019

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2019-05-31.

## Product

REVACLEAR 300 Dialyzer, Product Code 114745L     Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

## Reason for recall

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

## Distribution

US Nationwide Distribution and Internationally to: Canada and Bermuda.

## Key facts

- **Recall number:** Z-1908-2019
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-31
- **Report date:** 2019-07-10
- **Termination date:** 2020-10-05

- **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-1908-2019

## Citation

> AI Analytics. FDA recall Z-1908-2019. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1908-2019. Source: US FDA. Licensed CC0.

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