# FDA recall Z-1925-2018

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2018-04-24.

## Product

Prismaflex 7.XX US, Product Code 115269     Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

## Reason for recall

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a  Voltage Out of Range  malfunction alarm, which causes the device to enter a  safe state  and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

## Distribution

Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.

## Key facts

- **Recall number:** Z-1925-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-24
- **Report date:** 2018-05-30
- **Termination date:** 2021-06-22

- **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-1925-2018

## Citation

> AI Analytics. FDA recall Z-1925-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1925-2018. Source: US FDA. Licensed CC0.

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