FDA-Device2024-02-14Class II
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Maquet Medical Systems USA
Hazard
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.
Sold states
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.
Affected count
1090 total
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0978-2024Don't want to check this manually?
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