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Safety Report: Medline SubG Endotracheal Tubes with Subglottic Suction - recalled due to potential malfunction, USA

1 month ago source fda.gov

Recall notice

United States

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. Medline Industries, LP distributed product(s) within the United States.

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.

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 kit/tray SKUs are included in the scope of the recall can be viewed in the below link.

Products can be identified by their product labeling, which will indicate the name of the device and product number. Consumers who have SubG Endotracheal Tube with Subglottic Suction should stop using the device. No product is to be returned to Medline.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Medline Industries LP
Brand name: Medline
Product recalled: SubG Endotracheal Tubes with Subglottic Suction and kits that contain these devices
Reason of the recall: 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.
FDA Recall date: May 31, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-subg-endotracheal-tube-subglottic-suction

#medicaldevices #recall #us

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