Covidien Voluntarily Recalls Tracheostomy Tubes

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Last Friday, April 23, the US Food and Drug Administration (FDA) and the manufacturer Covidien notified healthcare professionals about a recall of its cuffed Shiley tracheostomy tubes and custom/specialty tracheostomy tubes.

The recall does not affect all, but only certain lots and is prompted by the product's cuff failure to hold air as a result of leaks in the pilot balloon inflation assembly.

With respect to the affected units, lack of proper air pressure in the cuff may prevent the cuff from sealing resulting in an inability to create positive air pressure in the airway and impaired ventilation.

This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.

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The list of the lots numbers affected by the voluntary recall is available on the FDA Website.

Tracheostomy Tubes Replacement

According to Covidien, a replacement product is available. To return the affected product for credit, contact the company's Technical Services group at 1-800-635-5267, option 3, then option 1, and reference the return goods authorization (RGA) number.

Adverse events related to these cuffs and tubes should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at FDA.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Source
FDA

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