The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots/batch of Rüsch Endotracheal Tube imported and distributed by East Lane Corporation.
Teleflex is initiating a Field Safety Corrective Action due to reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. In the event of the pilot balloon remaining flat, there is the potential risk of injury to the patient as the pilot balloon no longer reflects the condition of the cuff. The risk persists in situ, therefore clinicians should evaluate the risk benefit to individual patients of extubation and reintubation.
In light of the foregoing, all concerned healthcare professionals, establishments, and the general public are warned to discontinue further use, sale, and distribution of the Rüsch Endotracheal Tube.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.