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Class I Medical Device Recall: Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer S

Posted Aug 03 2010 9:00pm

Recall Class: Class I

Date Recall Initiated: April 21, 2010

Products: Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube

To see the specific reorder numbers and global part numbers for the products affected by this recall, please see the firm press release below under Useful Links.

These sets and trays were distributed from February 18, 2009 through April 27, 2010.

Use: The tracheostomy sets and trays areprescription devices used by the order of a physician.

A tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). A tracheostomy tube is usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.

Inflatable cuff tracheostomy tubes have a soft balloon around the far end of the tube that is inflated to seal off the space between the wall of the windpipe and the tracheostomy tube during mechanical ventilation. The cuff prevents air from the ventilator from leaking around the tracheostomy tube and prevents injury to delicate tissue in the windpipe.

Recalling Firm:

Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120

Reason for Recall:

These sets and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been the subject of a recall. Such tubes may leak air, resulting in inadequate ventilation. Use of these products can result in serious injury, including death.

Public Contact:

Customers may contact Cook Medical Customer Relations Department at 1-800-457-4500 or 1-812-339-2235, or by email at .

FDA District: Detroit

FDA Comments:

Cook Medical sent their recall notice to hospitals, other user facilities, and to distribution centers. The company directed hospitals to return the affected products, and the distribution centers to stop distributing the products and to notify their customers. For additional information, see the firm’s press release below.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAX.

Useful Links:

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