Medtech Recall Round-Up: June 2024Medtech Recall Round-Up: June 2024

Medline Sub-G Endotracteal Tube with Subglottic Suctioning

Medline Industries’ recall of the Sub-G Endotracheal Tube with Subglottic Suctioning has been upgraded to the most serious type, Class I, due to the possibility that affected devices could cause serious injury or death if used.

Medline initially recalled the endotracheal tube after reports of detachment or tearing of the inflation tube or other device components from the main tube, resulting in cuff leakage, deflation, moisture buildup, and failure to inflate. If it were to come apart using use, the company said, partial or total airway obstruction and choking could occur. There have also been reports that the “main tube is susceptible to tearing and the suction port is hard to connect or can detach during use,” according to FDAs Class I notice.

If affected stock were to be used, it could potentially cause serious adverse health consequences like low oxygen, unplanned removal of a breathing tube, need for pitting in a new breathing tube, ventilator associated pneumonia from regurgitation and aspiration of gastric contents, respiratory distress and cardiac arrest, no oxygen to the brain, tissue and organ damage, and death. Currently, there have been three reports of injuries connected to the recall and no deaths.