Getinge recalls oxygenators over sterility issues

Getinge's business Maquet recalled all lots of about 20 oxygenators and cardiotomy reservoirs because of a potential sterility issue in the packaging. 

The company said to continue using the affected Quadrox Oxygenator or specified Venous Hardshell Cardiotomy Reservoir devices if they are already in use and monitor patients for any signs of infection. 

The oxygenators provide physiological gas during cardiopulmonary bypass procedures and six-hour cardiopulmonary bypass procedures, and the cardiotomy reservoirs store and filter blood during those operations. 

If unused, here are the affected products that should be discarded: 

  • Cardiotomy reservoirs: VKMO 10000-USA and 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 and BEQ-HMO 51100

  • QUADROX-i: HMO 50000, HMO 51000, HMO 70000, HMO 71000, BEQ_HMO 71000, HMO 10000, HMO 11000, HMO 30000 and HMO 31000

The FDA said it is working with Getinge/Maquet to track adverse events.

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