# FDA recall Z-2489-2019

> **B. Braun Medical, Inc.** · Class I · device recall initiated 2019-05-01.

## Product

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

## Reason for recall

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

## Distribution

Distribution to US state of TX, and Canada.

## Key facts

- **Recall number:** Z-2489-2019
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-01
- **Report date:** 2019-10-02
- **Termination date:** 2020-07-13

- **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-2489-2019

## Citation

> AI Analytics. FDA recall Z-2489-2019. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2489-2019. Source: US FDA. Licensed CC0.

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