Summary: Medline Industries is recalling the Sub-G Endotracheal Tube with Subglottic Suction due to risks of detachment, tearing, and potential airway obstruction. The FDA has classified this as a serious recall, with reported injuries but no deaths. Affected customers are advised to respond to the recall notice.

Key Takeaways:

  • The recall addresses significant risks, including cuff leakage, airway obstruction, and potential for serious health consequences.
  • Affected customers should complete and submit the recall response form to receive credit and ensure patient safety.

Medline Industries, LP is recalling the Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other device components from the main tube, resulting in cuff leakage, deflation, moisture buildup, and failure to inflate. Additionally, if the device comes apart during use, partial or total airway obstruction and choking may 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.

Serious Health Risks

The use of affected Sub-G Endotracheal Tube with Subglottic Suction may cause serious adverse health consequences, including 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.

FDA Reports

The FDA has received three reports of injuries for the recalled devices. There have been no reports of death for the recalled devices. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Recall Notice

On February 26, 2024, Medline Industries, LP sent all affected customers an Immediate Action Required Medical Device Recall Notice recommending the following actions:

  • Complete the response form included in this notice and list the quantity of affected product you have in inventory.
  • Even if no affected product is identified, please complete and submit the response form.
  • Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form.

Purpose of the Sub-G Endotracheal Tube

The Sub-G Endotracheal Tube is used to help patients breathe by inserting it through the mouth and into the windpipe. It also helps drain fluids from the upper part of the windpipe. This tube is used to keep the airway open so that oxygen, medicine, or anesthesia can be given. It is often used for patients with conditions like pneumonia, emphysema, heart failure, a collapsed lung, or severe injuries. It also helps clear blockages from the airway.