# FDA recall Z-0550-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-11-15.

## Product

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

## Reason for recall

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-0550-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-15
- **Report date:** 2023-12-20

- **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-0550-2024

## Citation

> AI Analytics. FDA recall Z-0550-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0550-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*