FDA-Device2015-07-15Class I
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Hazard
Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
Sold states
Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Affected count
69,461 units total
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1951-2015Don't want to check this manually?
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