# FDA recall Z-0327-2025

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2024-10-16.

## Product

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607.  As of February 2025, the firm name is Vantive.

## Reason for recall

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

## Distribution

US Nationwide distribution and worldwide

## Key facts

- **Recall number:** Z-0327-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-16
- **Report date:** 2024-11-20

- **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-0327-2025

## Citation

> AI Analytics. FDA recall Z-0327-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0327-2025. Source: US FDA. Licensed CC0.

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