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Getinge / Maquet Cardiopulmonary GmbH Issues Medical Device Removal for Certain Lots of ROTAFLOW Centrifugal Pumps (RF-32 Pumps)

On January 8, 2024, Getinge / Maquet Cardiopulmonary GmbH (MCP) notified affected customers of a nationwide recall (medical device removal) for certain lots of ROTAFLOW Centrifugal Pumps (RF-32 pumps) due to a potentially compromised sterile barrier.  The RF-32 pumps are intended to maintain blood flow during extracorporeal circulation and are packaged in sterile bags supplied to MCP/Getinge from its supplier, Nelipak.

Please download the notice for more comprehensive information and instructions.

Medical Device Removal for Certain Lots of RF-32 ROTAFLOW Centrifugal Pumps Jan 8 2024 Download PDF

Medical Device Removal Notice - Quadrox

Maquet Cardiopulmonary GmbH/Getinge is initiating a voluntary Medical Device Removal for the Cardiotomy Reservoirs (VKMO 10000-USA, VKMO 11000-USA), QUADROX-iD (BEQ-HMOD 30000, HMOD 70000, and BEQ-HMOD 70000), QUADROX-iR (HMO 71100, HMO 70100, BEQ-HMO 71100, HMO 51100, HMO 50100, BEQ-HMO 51100), and QUADROX-, i (HMO 50000, HMO 51000, HMO 70000, HMO 71000, and BEQ_HMO 71000, HMO 10000, HMO 11000, HMO 30000 and HMO 31000) Oxygenators due to a risk of potentially compromised packaging sterility that may result in the risk of infection/harm to the patient. All lots are being removed. 

Please download the notice for more comprehensive information and instructions.

Quadrox Oxygenator Notice 18 May 2023 Download PDF