# FDA recall Z-0030-2020

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2018-10-10.

## Product

L5C4531 X1  Integrated APD Set with Cassette 3-Prong  Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

## Reason for recall

Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.

## Distribution

U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV.     No foreign (OUS) distribution.

## Key facts

- **Recall number:** Z-0030-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-10
- **Report date:** 2019-10-09
- **Termination date:** 2020-07-22

- **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-0030-2020

## Citation

> AI Analytics. FDA recall Z-0030-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0030-2020. Source: US FDA. Licensed CC0.

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