Summary

---

Company Announcement

On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate. It has also been reported that the main tube is susceptible to tearing. The primary health and safety risks due to these defects include increased risk of patient re-intubation, delay in case and/or treatment, respiratory distress from loss of ventilation, uncontrolled loss of airway gases, and, if the device comes apart during use, partial or total airway obstruction and choking. These may lead to inefficient ventilation or failure to ventilate and oxygenate, hypoxemia, carbon dioxide retention, acidemia, organ ischemia, cardiorespiratory arrest, regurgitation and aspiration of gastric contents, ventilator associated pneumonia, bradycardia, cardiac arrest, bleeding, tissue damage, and organ damage.

Consumers who have SubG Endotracheal Tube with Subglottic Suction should stop using and discard the device. No product is to be returned to Medline.

Recalled SubG Endotracheal Tube with Subglottic Suction were manufactured from March 01, 2021 to January 01, 2024 and distributed from March 01, 2021 to February 20, 2024.

The following kit/tray SKUs are included in the scope of the recall:

Additionally, the following finished good SKUs are included in the scope of the recall:

Products can be identified by their product labeling, which will indicate the name of the device and product number (see “REF” for reference to the product number).

Medline Industries, LP voluntarily recalled product after performing a thorough investigation of complaints filed for this issue. Medline Industries, LP has notified the FDA of this action.

At this time, Medline Industries, LP is not aware of any serious health consequences which have occurred due to use of the device.

Medline Industries, LP distributed product(s) within the United States, El Salvador and United Arab Emirates. Medline Industries, LP is notifying its distributors and customers by email and/or first-class mail and is arranging for credit of all recalled product(s).

Consumers with questions regarding this recall can contact Medline Industries, LP by phone at 866-359-1704 or recalls@medline.com Monday through Friday between the hours of 8am and 5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this medical device.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178