Endotracheal Tubes Recalled by Manufacturer

Potential for disconnection results in review

Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient from the breathing circuit, which may result in insufficient oxygenation, decrease in vital signs, or death.

Four deaths and 18 injuries have been reported to Teleflex in association with disconnection. However, Centurion has no reported injuries or complaints. The use of affected product may cause serious adverse health consequences, including death.

Centurion issued a customer notification letter on July 3, 2019, to Medline, the parent company and sole customer for this product, to communicate with affected customers, instructing customers to identify the affected product within their inventory and return it immediately.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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