June 12, 2024

Endotracheal tube component failures prompt FDA Class I recall

Editor's Note

The US Food & Drug Administration has designated Medline Industries’ recall of the Sub-G Endotracheal Tube with Subglottic Suction, which is used to keep a patients’ airway open, as a class 1, the most severe category indicating risk of serious injury or death.

According to the agency’s June 11 report, detachment or tearing of the inflation tube and other device components could result in cuff leakage, deflation, moisture buildup, and failure to inflate. For patients, such problems could result in chocking as well as “low oxygen (hypoxemia), unplanned removal of a breathing tube (forced extubation), need for putting in a new breathing tube (re-intubations), ventilator associated pneumonia from regurgitation and aspiration of gastric contents, respiratory distress and carbon dioxide accumulation (acidosis) from inefficient ventilation or failure to ventilate, cardiac arrest, no oxygen to the brain (brain anoxia), tissue and organ damage, and death.”

There have been three reports of injuries and no deaths associated with the device. In a February 26 notice, Medline advised affected customers to document and destroy affected product.

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