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FDAJanuary 8, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

maquet medical systemsmaquetmaquet medical

UPCs

4037691530864

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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