# FDA recall Z-0314-2018

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2017-08-22.

## Product

Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK.     In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

## Reason for recall

Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.

## Distribution

Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.

## Key facts

- **Recall number:** Z-0314-2018
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-22
- **Report date:** 2018-01-10
- **Termination date:** 2025-04-14

- **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-0314-2018

## Citation

> AI Analytics. FDA recall Z-0314-2018. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0314-2018. Source: US FDA. Licensed CC0.

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