Maquet Medical Systems USA recalls BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal ca…

Recall date

January 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0978-2024

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.