medical Class II Updated 2024-02-14

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070; 3000355577; 3000358977
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →