# FDA recall Z-2149-2019

> **Maquet Cardiovascular Us Sales, Llc** · Class II · device recall initiated 2019-07-11.

## Product

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794

## Reason for recall

The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.

## Distribution

The products were distributed to the following US states:  AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI.

## Key facts

- **Recall number:** Z-2149-2019
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-11
- **Report date:** 2019-09-25
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2149-2019

## Citation

> AI Analytics. FDA recall Z-2149-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2149-2019. Source: US FDA. Licensed CC0.

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