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Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes
Manager, Media and Public Relation
Respiratory and Monitoring Solutions
Coleman Lannum, CFA Vice President
FOR IMMEDIATE RELEASE - April 23, 2010 – BOULDER, CO - Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM 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 - ShileyTMTracheostomy Products
The lot numbers for all Shiley dual cannula tracheostomy tubes are clearly printed on the left side of the Soft Swivel Flange and on the carton and pouch or tray lid, depending on the product configuration. For all other tracheostomy tubes, the lot number can be found on the carton and pouch or tray lid.
For the products listed in Table 1 above: Products with lot codes where the first four numbers are in the range from 0810 to 0908 may be affected; consult Table 1 for specific lot code ranges for each product code. Products in the above Table 1 with lot code numbers starting with 0809 or lower, and those with lot code numbers starting with 0909 or higher, are not affected.
Table 2 – Custom ShileyTM Tracheostomy Products
The lot number of Custom/Specialty tracheostomy tubes is clearly printed on the left side of the Soft Swivel Flange and on the carton and pouch in which the product was shipped.
For the products listed in Table 2 above: Products with lot codes where the first four numbers are in the range from 0904 to 0912 may be affected; consult Table 2 for specific lot code ranges for each product code. Products in the above Table 2 with lot code numbers starting with 0903 or lower, and those with lot code numbers starting with 1001 or higher, are not affected.
Customers were notified of this issue by a Customer Notification letter April 13, 2010, which is posted at http://respiratorysolutions.covidien.com/AirwayManagement/tabid/234/Default.aspx. Then click on the Product Notices tab.
The company believes it has taken appropriate steps to address this issue. Adequate supplies of unaffected replacement product are available.
To return the affected product for credit, contact Technical Services group at 1-800-635-5267, option 3, then option 1, and reference the Return Goods Authorization (RGA) Number.
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-332-0178
- Phone: 1-800-332-1088