Recall on Pediatric Tracheostomy Tubes
Rick PattersonMarch 11, 2009 6:00 AM
According to the FDA, a class 1 recall is being issued on pediatric tracheostomy tubes manufactured from July 7, 2008, through December 9, 2008, and distributed from July 24, 2008, through December 23, 2008. The tubes are manufactured by Covidien Inc.
"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 tubes recalled are said to be difficult to assemble as they require that one component be inserted into another. One component is used to place the tracheostomy tube into the windpipe and the other is a catheter suction tube.
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.
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.