# FDA recall Z-0123-2024

> **B. Braun Medical, Inc.** · Class I · device recall initiated 2023-09-21.

## Product

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

## Reason for recall

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions.  In some cases, this may be life-threatening or may lead to death.

## Distribution

Domestic distribution nationwide. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-0123-2024
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-21
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2024

## Citation

> AI Analytics. FDA recall Z-0123-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0123-2024. Source: US FDA. Licensed CC0.

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