The U.S. Food and Drug Administration has announced a recall of certain endotracheal tubes made by the company Teleflex amid concerns that use of the tubes can lead to serious injury and death. The recall has been categorized as a Class I recall, which the FDA reserves for only the most serious types of recalls.
Recall Information for Teleflex Sheridan Endotracheal Tubes
The product at issue in this recall is the Sheridan Endotracheal Tube. These tubes have been packaged with an airway kit manufactured by Centurion. The kits are used to maintain adequate oxygen in patients undergoing surgery and patients with oxygen deprivation. The tubes open the airway and release an anesthetic if a patient has inadequate respiration.
According to information in an FDA Safety Communication, the Sheridan Endotracheal Tubes can pose a risk to patients, as the tube connector can become dislodged from the tube, which leads to a disconnection from the breathing circuit. A disconnection can cause a patient to have insufficient oxygen, exposing the patient to the risk of hypoxic or anoxic injury and even death.
Teleflex informed the FDA that it had received 18 reports of injuries related to issues with the Sheridan Endotracheal Tubes and four reports of death. The airway kit manufacturer, Centurion, said it had received no injury or death reports.
The model number for the kit is TC 7855, and the model number for the component is TTCONGo. The tubes were distributed between November 28, 2018, and June 5, 2019, to Medline. This recall includes the Hudson RCI Sheridan, as well. Approximately 80 kits containing the Sheridan Endotracheal Tubes were sold in the United States during this time, with 70 additional components sold outside of kits.
FDA Advisement for Health Care Providers and Patients
Persons who might be affected by this recall include patients who had surgical procedures from November 28, 2018, to June 5, 2019, that involved the use of general anesthesia. A Centurion Airway Kit with Sheridan Endotracheal Tubes could have been used during the procedure to provide oxygen support. In addition, health care providers and distributor companies that bought the Centurion Airway Kit with Sheridan Endotracheal Tubes are affected by the recall.
Patients themselves should not be in possession of the recalled endotracheal tubes, but patients could have developed injuries from their use in a medical setting. Patients often do not know all of the medical devices used during their surgeries or do not know the brands of products used. A list of devices and product identification can be obtained by ordering medical records for relevant procedures from the medical facility where those procedures were performed. Patients who suffered an oxygen deprivation injury should be able to determine if a recalled product was used by examining the medical records.
The FDA stated that Centurion informed Medline (the primary customer of the product) about the recall in July, and Medline should be issuing communication to affected customers. Customers should check the brand and model number on airway kits and endotracheal tubes in their possession, and return recalled product to the manufacturer/seller. Questions can be directed to Centurion at (517) 545-1156.
How You Can Report Adverse Events to the FDA
Patients can report complications and injuries from medical devices directly to the FDA by using the FDA’s system MedWatch – Safety Information and Adverse Event Reporting Program. Patients can access the system online and can fax reports to (800) FDA-0178.
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