Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tra…

Recall date

May 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1951-2015

FDA classification

Class I

Brand / firm

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Sold / distributed

Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.