Covidien Inc. is recalling several lots of Shiley 3.0PED Cuffless Pediatric Tracheostomy Tubes because practitioners have reported difficulty inserting two of the device’s components during procedures. The action has been deemed a Class I recall, the Food & Drug Administration’s (FDA) most urgent type of recall. Class I recalls are issued when there is a reasonable probability that use of a product will cause serious injury or death.
The Covidien Pediatric Tracheostomy Tube recall involves the following lot numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547, 0811001875.
The tracheostomy tubes were manufactured from July 7, 2008 through December 9, 2008 and distributed from July 24, 2008 through December 23, 2008.
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. Practitioners have reported difficulty inserting the device used to place the tracheostomy tube into the windpipe (obturator). There have also been similar reports of difficulty involving the insertion of a suction tube (catheter) into the tracheostomy tube. In some instances, these problems have required that the tracheostomy tube be removed and replaced.
According to the recall notice, Covidien sent an urgent alert letter to its customers on January 14, 2009 notifying them of the problem. The company began sending a second letter to their customers on March 6, 2009 asking them to remove all remaining affected products from their inventory, and return them for replacement or credit.
Customers with questions about the Covidien Pediatric Tracheostomy Tube recall may contact the company at 1-800-635-5267.
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