FDAMay 8, 2015device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

covidien lp formerly nellcor puritan bennett inccovidiencovidien lp

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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