# FDA recall Z-0272-2023

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2022-10-10.

## Product

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment.    Used for infusion 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 delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

## Distribution

US distribution to states of: Indiana, Texas and Virginia

## Key facts

- **Recall number:** Z-0272-2023
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-10
- **Report date:** 2022-11-30

- **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-0272-2023

## Citation

> AI Analytics. FDA recall Z-0272-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0272-2023. Source: US FDA. Licensed CC0.

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