# FDA recall Z-2285-2018

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2018-05-09.

## Product

Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420    The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.

## Reason for recall

There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.

## Distribution

US Distribution to the states of :  CA, IL, and TX., and Internationally to Canada.

## Key facts

- **Recall number:** Z-2285-2018
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-09
- **Report date:** 2018-07-04
- **Termination date:** 2019-12-12

- **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-2285-2018

## Citation

> AI Analytics. FDA recall Z-2285-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2285-2018. Source: US FDA. Licensed CC0.

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