The FDA is reminding healthcare providers and facilities about the recent recall of certain oxygenators used for extracorporeal circulation.
The US Food and Drug Administration is reminding healthcare providers and facilities about the recent recall of certain oxygenators used for extracorporeal circulation.alerting users not use any Quadrox oxygenator and certain Getinge/Maquet venous hardshell cardiotomy reservoirs due to a potential sterility issue with the packaging that could result in the risk for infection or patient harm, the FDA says in a letter to healthcare professionals.
The venous hardshell cardiotomy reservoir is used to collect, store, and filter blood in extracorporeal circulation in CPB procedures for up to 6 hours. The FDA recommends that providers and facilities who use Getinge/Maquet Quadrox oxygenators and venous hardshell cardiotomy reservoirs take the following actions:Check inventory for any recalled product.If a Quadrox oxygenator or specified venous hardshell cardiotomy reservoir is already in use, these devices may continue to be used. Patients should be monitored for inflammation, infection, sepsis, and ischemia, and, if detected, treated according to clinical protocols.
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