From Medscape Medical News 3/11/09
Emma Hitt, PhD
Medscape Medical News 2009. © 2009 Medscape
March 10, 2009 — A class 1 recall is being issued on selected lots of pediatric tracheostomy tubes (Shiley 3.0PED Cuffless Pediatric Tracheostomy Tubes, Covidien Inc) manufactured from July 7, 2008, through December 9, 2008, and distributed from July 24, 2008, through December 23, 2008, the US Food and Drug Administration (FDA) says.
The recall is being issued because of complaints received about the difficulty of inserting 2 components: the device used to place the tracheostomy tube into the windpipe (the obturator) and the catheter suction tube, which is inserted into the tracheostomy tube.
"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," the FDA notes in the recall notice.
The company issued an urgent alert letter to customers on January 14, 2009; a second letter issued on March 6, 2009, recommends that healthcare professionals remove all remaining affected products and return them to the manufacturer for replacement or credit. The manufacturer may be contacted by telephone at 1-800-635-5267.
Specific lot numbers affected are as follows: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547, and 0811001875.
Adverse events or quality problems associated with the use of these products should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.