# FDA recall Z-1684-2021

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2021-04-14.

## Product

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

## Reason for recall

There is a potential leak between the venous patient connector and patient's hemodialysis access.

## Distribution

Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.

## Key facts

- **Recall number:** Z-1684-2021
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-14
- **Report date:** 2021-06-02
- **Termination date:** 2024-05-10

- **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-1684-2021

## Citation

> AI Analytics. FDA recall Z-1684-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1684-2021. Source: US FDA. Licensed CC0.

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