FDA Tells Providers to Destroy Recalled Endotracheal Tubes

Pieces can detach and cause choking hazards or cause patients to not receive enough oxygen.

FDA

Jun 14, 2024

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This recall involves removing devices from where they are used or sold.

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.

Affected Product

Product Names: Medline Sub-G Endotracheal Tube with Subglottic Suctioning
Unique Device Identifier (UDI)/Model: This recall includes 6 Sub-G Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. See the full list of affected devices.
Lot/Serial Numbers: All lots from the series line of Sub-G Endotracheal Tubes with Subglottic Suction

What to Do

Immediately check stock for the affected item number and the affected lot numbers.
Destroy any affected inventory.

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.
Share this recall communication with any company or individual that have bought or received this product. Request that customers document and destroy any affected product.
- Include any customer quantities on the response form.

Reason for Recall

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.

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.

The FDA has received three reports of injuries for the recalled devices. There have been no reports of death for the recalled devices.

Device Use

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.