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Medline Reaps FDA Ire in Class I Endotracheal Tube Recall

The company has been under FDA spotlight since its link to the China plastic syringe manufacturing safety communication was announced earlier this year.

Katie Hobbins, Managing Editor

June 17, 2024

3 Min Read
FDA Headquarters
Sarah Silbiger / Stringer / Getty Images News via Getty Images

FDA last week announced that Medline Industries’ recall of the Sub-G Endotracheal Tube with Subglottic Suctioning has been upgraded to the most serious type, Class I, due to the possibility that affected devices could cause serious injury or death if used.

A Sub-G Endotracheal Tube with Subglottic Suctioning is inserted in the mouth and into the windpipe to help patients breathe, or to drain fluids from the upper part of the windpipe. Additionally, the tube can be used to keep airways open so that oxygen, medicine, or anesthesia can be administered to patients with conditions like pneumonia, emphysema, heart failure, a collapsed lung, or severe injuries. It can also help clear blockages from the airway.

Medline initially recalled the endotracheal tube after reports of detachment or tearing of the inflation tube or other device components from the main tube, resulting in cuff leakage, deflation, moisture buildup, and failure to inflate. If it were to come apart using use, the company said, partial or total airway obstruction and choking could occur. There have also been reports that the “main tube is susceptible to tearing and the suction port is hard to connect or can detach during use,” according to FDAs Class I notice.

If affected stock were to be used, it could potentially cause serious adverse health consequences like low oxygen, unplanned removal of a breathing tube, need for pitting in a new breathing tube, ventilator associated pneumonia from regurgitation and aspiration of gastric contents, respiratory distress and cardiac arrest, no oxygen to the brain, tissue and organ damage, and death. Currently, there have been three reports of injuries connected to the recall and no deaths.

Related:Merit Medical Recalls Plastic Syringes Made in China

Medline contacted affected customers on Feb. 26, 2024, through an Immediate Action Required Medical Device Recall Notice recommending they check stock to confirm whether affect product is present. If so, the company said it would issue credit for the product based upon the quantity and lot number identified. The recall includes six Sub-G Endotracheal Tubes with Subglottic Suction and 10 kits that contain the devices.

This is just the latest struggle in Medline’s tangle with FDA in 2024. The company, in March, was linked to the agency’s safety communication evaluation the quality and performance issues related to plastic syringes made in China. FDA issued warning letters to multiple firms, including Medline, at the time that described violations related to the sale and distribution of unauthorized plastic syringes made in the country that have not been cleared or approved by the agency for such purposes.

Additionally, Medline also received a warning letter, along with the likes of Sol-Millennium Medical, concerning violations to quality system regulations for syringe products. The company is linked to Jiangsu Caina Medical, a China-based manufacturer, producing the product for Medline to market, sell, and distribute in the US, according to the notice.

The company has since initiated recalls to stop using affected syringes made in China including unauthorized plastic syringes, those contained in convenience kits, plastic syringes with performance testing failures, as well as its in-bulk equivalents.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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