# FDA recall Z-0977-2024

> **Maquet Medical Systems USA** · Class II · device recall initiated 2024-01-08.

## Product

BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.

## Reason for recall

Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.

## Distribution

Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR,  PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.

## Key facts

- **Recall number:** Z-0977-2024
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-08
- **Report date:** 2024-02-14

- **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-0977-2024

## Citation

> AI Analytics. FDA recall Z-0977-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0977-2024. Source: US FDA. Licensed CC0.

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