# FDA recall Z-2137-2021

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2021-06-25.

## Product

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

## Reason for recall

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

## Distribution

Affected products were distributed to the following US states:  CA, MI, OR, and UT.

## Key facts

- **Recall number:** Z-2137-2021
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-25
- **Report date:** 2021-08-04
- **Termination date:** 2023-10-16

- **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-2137-2021

## Citation

> AI Analytics. FDA recall Z-2137-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2137-2021. Source: US FDA. Licensed CC0.

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