AR: Covidien is recalling some of the company's Shiley cuffed tracheostomy tubes because a leak in the pilot balloon assembly may cause the cuff to lose air. If a cuff doesn't stay inflated, a patient's ventilation could be compromised, which could lead to serious injury or death.
MB: The recall affects certain lots of Shiley tracheostomy tubes and custom/specialty tracheostomy tubes. You can find those lot numbers by going to our website.
AR: Healthcare facilities with unused tubes from the recalled lots should segregate them and return them to the company. If a tube from the recalled lots is being used in a patient, Covidien says to replace the affected tube with one that's not being recalled as soon as it's clinically appropriate. If the patient's physician wants to wait for a more acceptable opportunity to replace the tube, the company recommends increased monitoring of the patient's cuff inflation system.
MB: Patients and caregivers using cuffed Shiley tracheostomy tubes at home should also check the lot numbers of their products. If they have unused tubes from the recalled lots, or if they can't tell if their tubes are included in the recall, they should contact their home care or medical equipment provider. If the tracheostomy tube currently being used in the patient is or may be one of the recalled tubes, the patient or caregiver should call their clinician for advice.

标题
Cuffed Tracheostomy Tube Recall (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
Covidien is recalling some of the company's Shiley cuffed tracheostomy tubes because a leak in the pilot balloon assembly may cause the cuff to lose air.

Speaker #1: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration

Speaker #2: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration