Covidien Shiley Adult Tracheostomy Tubes Recalled due to Leakage And/or Disconnection

The US FDA notifies Consumers, Health Professionals and Home Care professionals that Covidien Shiley Adult Tracheostomy Tubes are recalled because of reports concerning volume leakage and/or disconnection during patient ventilation.

Background of Covidien Shiley Adult Tracheostomy Tubes

Shiley Adult Tracheostomy Tube, by Covidien LP, is used during tracheostomy and is placed through the trachea to provide an airway to the patient and a pathway for fluid removal. FDA Alert on Covidien Shiley Adult Tracheostomy Tubes

FDA’s reason for the recall is that consumers reported errors of volume leakage and/or disconnection between the inner and outer cannulae with Covidien Shiley Adult Tracheostomy Tubes during patient ventilation.

The affected lots of Shiley size 8 adult, reusable, cuffed tracheostomy tubes are:

Product Code: 8FEN, Lot numbers from 0910000342 to 1101001558

Product Code: 8FEN, Lot numbers from 110201893X to 120600700X

Product Code: 8LPC, Lot numbers from 0910000346 to 1101001823

Product Code: 8LPC, Lot numbers from 110200327X to 120600351X.

The affected lots manufacture dates were from October 1, 2009, to June 26, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Covidien Shiley Adult Tracheostomy Tubes

 “Customers should return all Shiley tracheostomy tubes from the affected models and lots to Covidien. If one of the recalled tubes is already in use in a patient, Covidien recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, Covidien strongly encourages that the frequency of direct patient observation be increased.”

Contacting the FDA to report cases with Covidien Shiley Adult Tracheostomy Tubes

In case of detection of adverse events or side effects related to the use of Covidien Shiley Adult Tracheostomy Tubes, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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