FDA recalls breathing system filters after multiple injuries
The U.S. Food and Drug Administration is alerting the public to a recall of bidirectional breathing system filters after reports of serious injuries. The manufacturer, Draeger, alerted all known customers to the dangers in a letter sent on July 22. Both the company and the FDA said no deaths have been reported.
The filters in question are the Draeger SafeStar and TwinStar, used in mechanical ventilation to protect patients from bacteria and viruses. They are commonly employed during surgeries that require anesthesia.
A defect in the filters can cause breathing systems to display inaccurate carbon dioxide readings. This has led healthcare providers to administer unnecessary treatments and compensatory measures, which may have resulted in patient injuries.
Because of the high patient safety risk—including airway injury and potential death—the FDA has designated this a Class I recall, the most serious type.
What is being recalled?
The following chart shows all Draeger SafeStar and TwinStar filters subject to this recall.
Next steps
Any filter that matches the list above must be quarantined and immediately removed from inventory and clinical use. These filters cannot be used safely. Healthcare providers and hospitals should identify and implement alternative filters for breathing systems.
All products affected by the recall should be returned to Draeger for a refund. To arrange a return, contact Draeger at 1-800-437-2437, press 2 then 1, or by email at [email protected].
The FDA asks that the recall notice be shared to spread awareness. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.