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FDA recalls airway kits containing certain endotracheal tubes

The FDA has issued a class 1 recall of Centurion Medical Products’ airway kits containing Sheridan Endotracheal Tubes used when patients cannot maintain sufficient respiratory function.

The recall affects 80 kits and 70 components not included in kits that were distributed between Nov. 28, 2018 and June 5, 2019.

The recall by Centurion Medical Products affects two model numbers (Kit TC7855 and Component TTCONGo) and was brought to the company’s attention by Teleflex, a company that produced and recalled the endotracheal tubes in their kits. Teleflex has had several reports of the endotracheal tube connector dislodging from the endotracheal tube, according to a MedWatch report from the FDA. This results in a disconnection of the patient from the breathing circuit and may lead to a decrease in vital signs, insufficient oxygenation or death.

Centurion Medical Products have received no reports of complaints or injuries. Teleflex has received reports of four deaths and 18 injuries associated with the disconnection, according to the report.

Centurion Medical Products issued a notification letter on July 3, 2019 to Medline, the parent company and sole customer of the product. The letter alerted them to contact the affected customers about identifying and returning affected products, according to the report.