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

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 1090 total Lot/code info: UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070; 3000355577; 3000358977

UPC codes

4037691530864

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.