# FDA recall Z-0610-2020

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2019-10-28.

## Product

Medfusion Syringe Pump, Model 4000.  The Model 4000 pump is a small, lightweight and portable syringe infusion pump.  The pump offers a variety of delivery modes programmable to meet specific patient care needs.

## Reason for recall

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

## Distribution

CO, MD, NY

## Key facts

- **Recall number:** Z-0610-2020
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-28
- **Report date:** 2019-12-18
- **Termination date:** 2024-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0610-2020

## Citation

> AI Analytics. FDA recall Z-0610-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0610-2020. Source: US FDA. Licensed CC0.

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