Recall -- Firm Press Release

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Cook has initiated a voluntary recall of certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube

Company Contact: 
Cook Medical Customer Relations Department 
1-800-457-4500 or 1-812-339-2235
CustomerRelationsNA@CookMedical.com

FOR IMMEDIATE RELEASE – July 20, 2010 – BLOOMINGTON, IN – Cook has initiated a voluntary recall of certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube. 

Covidien has initiated a voluntary recall of certain lots of its cuffed Shiley™ 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.  Cook has mailed a detailed Customer Notification letter to each customer who has received an affected lot number of these devices.  Customers should review product in inventory and current use to identify product from the affected lot codes.  Detailed steps are provided in the Customer URGENT: PRODUCT RECALL letter for return and disposition of affected product(s).

Table 1.  Ciaglia Blue Rhino Products 

Table 2. Ciaglia Blue Dolphin Products

Customers were notified of this issue by an URGENT: PRODUCT RECALL Customer Notification letter mailed on April 21, 2010.  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 the Customer Relations Department of Cook Medical at 1-800-457-4500 or 1-812-339-2235.  Fax inquiries can be sent to 1-812-339-7316.  E-mail communications should be sent to CustomerRelationsNA@CookMedical.com. 

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.

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Online: www.fda.gov/medwatch/report.htm
Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787.
Fax: 1-800-FDA-0178 Phone: 1-800-332-1088

Photos: Product Labels

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