Maquet Medical Systems USA: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. 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 4037691650326 Lots 3000283239 and 3000330438 ***Lots added 3/21/24*** 3000334430; 3000344495; 3000351245

UPC codes

4037691650326

Source

Official record: FDA (Device enforcement) ↗

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