The FDA is notifying consumers that Medline Industries, LP has recalled its Medline Sub-G Endotracheal Tube with Subglottic Suctioning because of a device defect that causes the inflation tube and other components to detach or tear from the main tube.
Initiated by the firm on June 11, 2024, the recall has been identified as Class I, the most serious type, because the potential breakage during use may cause a partial or complete airway obstruction. In addition to being a choking hazard, the issue may also lead to “cuff leakage, deflation, moisture buildup, and failure to inflate.” Medline Industries, LP has also received reports that indicated the main tube is prone to tearing. Other reports described difficulty in connecting or detaching the suction port during use.
Consumers are warned that they could be subjected to any of the following adverse health consequences while using an affected Sub-G Endotracheal Tube with Subglottic Suction:
- hypoxemia, or low oxygen
- forced extubation, or unexpected removal of a breathing tube
- re-intubations, or the need for placement of a new breathing tube
- ventilator-related pneumonia due to “regurgitation and aspiration of gastric contents”
- respiratory distress and acidosis, or carbon dioxide accumulation, due to “inefficient ventilation or failure to ventilate”
- cardiac arrest
- brain anoxia, or lack of oxygen to the brain
- tissue and organ damage
- death
While the FDA has been notified of three reports of injuries in connection to the affected devices, no deaths have been reported.
Designed to help patients breathe and drain fluids from the upper part of the windpipe, the Sub-G Endotracheal Tube is inserted “through the mouth and into the windpipe.” It is typically used to maintain an open airway for the administration of oxygen, medicine, or anesthesia in patients suffering from “pneumonia, emphysema, heart failure, a collapsed lung,” or other major injuries and conditions. In other cases, the tube also helps to clear obstructions in the airway.
Consumers should be aware that the recall covers the Sub-G Endotracheal Tubes with Subglottic Suction under 6 Unique Device Identifiers (UDI) and all lot numbers. 10 kits containing the devices are also included in the recall.
Healthcare providers are asked to immediately assess facility inventory for any devices matching impacted item numbers and lot numbers. Any devices identified as such should be destroyed.
A communication labeled “Immediate Action Required Medical Device Recall Notice” sent to all affected Medline Industries, LP customers on February 26, 2024, made the following requests:
- Fill out the attached response form and itemize any affected products currently in inventory.
- In the event that no affected product has been identified, the response form should still be completed and submitted.
- Customers should expect to be issued credit for the device depending on the quantity and lot numbers provided on the response form.
- Any company or individual who may have received the affected product should be forwarded the recall communication and asked to document and destroy the item.
- The response form should include all customer quantities.
For more information about the recall, U.S. customers may call 866-359-1704 or email recalls@medline.com to reach out to the Medline Recall Department.
As the FDA continues to oversee the recall, healthcare professionals and consumers are encouraged to reported any related adverse events to the agency’s MedWatch program.
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