The US Food and Drug Administration (FDA) has issued a Class I classification to Medline’s recall of endotracheal tubes following reports of device failures.
Class I indicates the agency’s most serious designation for a recall, meaning continued use of the products, without actions being taken, could cause serious injury or death.
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Medline issued a notice to customers of its Sub-G Endotracheal Tube with Subglottic Suctioning device to destroy any affected inventory.
There are 168,632 tubes and 13,092 kits affected, according to the FDA’s recall database.
The devices are used to help patients breathe by draining fluids from the upper part of the windpipe. This tube keeps the airway open, allowing oxygen, medicine, or anaesthesia to be administered. Patients with pneumonia, heart failure, and a collapsed lung, among other conditions, are the most frequent targets of Medline’s tubes. It is also used to clear blockages from the airway.
As per the FDA notice, this recall involves “removing devices from where they are used or sold.”
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By GlobalDataThe tubes are being recalled due to detachment or tearing of the inflation tube and the main tube components. This is causing cuff leakage, moisture build-up, and failure to inflate.
The FDA stated that if the detachment occurs during therapy, airway obstruction and choking may occur. Reports also cite the main tube is susceptible to tearing and issues around suction port connections.
The agency listed a range of serious health consequences from continued use of the device, including low oxygen, respiratory distress, and cardiac arrest, amongst others. The potential for brain anoxia, organ damage, and death were also listed on the recall notice. There have been three reports of injuries due to the device.
This is the second recall in quick succession for Medline after 1.5 million bed rails manufactured by the company were recalled at the end of last month. Two deaths were reported due to entrapment between the rails.
