Maquet Medical Systems USA recalls BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating
Recalled Product
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Hazard / Issue
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.
Issued by
FDA
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