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U.S. Department of Health and Human Services

Medical Devices

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Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube

Class 1 Recall
Date Recall
Initiated:
January 14, 2009
Product:

Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube

Lot Numbers:

0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547, 0811001875

This product was manufactured from July 7, 2008 through December 9, 2008 and distributed from July 24, 2008 through December 23, 2008.

Use:
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.
Recalling Firm:
Covidien
Respiratory and Monitoring Solutions
6135 Gunbarrel Ave
Boulder, CO 80301
Reason for Recall:
The company has recalled this product because of complaints received about difficulty inserting: 1) the device used to place the tracheostomy tube into the windpipe (obturator), and/or 2) a suction tube (catheter) into the tracheostomy tube. This problem may require that the tracheostomy tube be removed and replaced.
Public Contact:
The company may be contacted at 1-800-635-5267.
FDA District:
Denver
FDA Comment:

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.

 

Class 1 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 injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program.  See the nearby link to MedWatch.