Class 1 Recall: Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube

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.

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.

The company may be contacted at 1-800-635-5267.

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.

For more information about this recall, please see the company’s press release at: http://www.nellcor.com/legal/prodnotices.aspx

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 either online, by regular mail or by FAX.

• 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-FDA-0178