Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

Date of Recall

2010-04-23

Recall Details

- April 23, 2010 - BOULDER, CO - Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed Shiley^TM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product's cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. 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.

The voluntary recall only affects lot numbers from a specific period of time. Only Shiley tracheostomy tubes from lot numbers listed below are affected by this action. Customers should review product in inventory and current use to identify product from the affected lot codes. Detailed steps are provided in the Customer Notification letter for return and disposition of affected product.

Table 1 - Shiley^TMTracheostomy Products

Item

Starting Lot Number

Ending Lot Number

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