# FDA recall Z-2734-2020

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2020-06-26.

## Product

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

## Reason for recall

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

## Distribution

Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago

## Key facts

- **Recall number:** Z-2734-2020
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-26
- **Report date:** 2020-08-12

- **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-2734-2020

## Citation

> AI Analytics. FDA recall Z-2734-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2734-2020. Source: US FDA. Licensed CC0.

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