# FDA recall Z-2173-2021

> **BAXTER HEALTHCARE CORPORATION** · Class II · device recall initiated 2021-06-30.

## Product

Sharesource Connectivity Platform for Use with the Amia Automated PD System

## Reason for recall

Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode.  In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

## Distribution

Worldwide distribution - US Nationwide distribution and the country of Japan.

## Key facts

- **Recall number:** Z-2173-2021
- **Recalling firm:** BAXTER HEALTHCARE CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-30
- **Report date:** 2021-08-11
- **Termination date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Round Lake, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2173-2021

## Citation

> AI Analytics. FDA recall Z-2173-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2173-2021. Source: US FDA. Licensed CC0.

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