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The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA is issuing this letter to help ensure that health care providers and facilities are aware of a recall notice by Getinge/Maquet for Quadrox Oxygenators and have information about alternative devices.
The Letter to Health Care Providers includes important information about this issue, including:
- Recommendations for health care providers and facilities
- Actions the FDA is taking to address the issue
- How to contact the FDA if you are having any issues with oxygenators
Questions?
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
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