Monday, July 15, 2024

Endotracheal Tube Recall by Medline Tagged as Class I by FDA

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Endotracheal tube recall by Medline has been classified as a Class I recall, the U.S. Food and Drug Administration’s (FDA) most serious designation. This classification indicates that the continued use of these products could result in serious injury or death if corrective actions are not taken. The endotracheal tube recall involves the Sub-G Endotracheal Tube with a Subglottic Suctioning device, with customers being instructed to destroy any affected inventory.

According to the FDA’s recall database, the recall affects 168,632 tubes and 13,092 kits. These devices are crucial for assisting patients with breathing by draining fluids from the upper part of the windpipe. They keep the airway open, allowing for the administration of oxygen, medicine, or anesthesia. Medline tubes are frequently used for patients with conditions such as pneumonia, heart failure, and a collapsed lung, as well as for clearing airway blockages.

FDA Warns of Severe Health Risks Including Airway Obstruction and Cardiac Arrest

The endotracheal tube recall has been prompted by reports of detachment or tearing of the inflation tube and the main tube components. These issues are leading to cuff leakage, moisture build-up, and failure to inflate properly. The FDA has noted that if detachment occurs during therapy, it could result in airway obstruction and choking. Additionally, the main endotracheal tube has been reported to be susceptible to tearing, and there are problems with the suction port connections.

The FDA’s recall notice lists a range of serious health consequences that could arise from the continued use of these defective devices. These include low oxygen levels, respiratory distress, cardiac arrest, brain anoxia, organ damage, and potentially death. So far, there have been three reported injuries linked to the device’s failure. Medline’s endotracheal tube recall notice advises that the affected devices be removed from wherever they are used or sold. This action is intended to prevent further incidents of device failure that could have severe health implications for patients.

Endotracheal Tube

Endotracheal Tubes and Bed Rails Highlight Urgent Need for Quality Control in Medical Devices

This endotracheal tube recall is the second significant recall for Medline in a short period. Just last month, the company had to recall 1.5 million bed rails after reports of two deaths due to entrapment between the rails. This series of recalls highlights the critical importance of stringent quality control and prompt corrective actions in the medical device industry to ensure patient safety.

In conclusion, the FDA’s Class I designation of the Medline endotracheal tube recall underscores the severity of the potential risks associated with these devices. The recall affects a significant number of tubes and kits, and the reported issues with the devices could have dire health consequences if not addressed. Medline’s swift action to instruct customers to destroy affected inventory is a necessary step to mitigate further risks. This situation also serves as a reminder of the importance of robust safety and quality control measures in the manufacturing and distribution of medical devices.

 

Resource: Food and Drug Administration, June 10, 2024

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