Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties
FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Shiley Neonatal, Pediatric, and Long Pediatric Tracheostomy Tubes with TaperGuard Cuff. The recall involves 69,461 units manufactured by Covidien LP (formerly Nellcor Puritan Bennett Inc.). These devices are intended for providing tracheal access for airway management.
The recall was initiated following reports that patients who switched to these affected products experienced discomfort and, in some cases, breathing difficulties. These symptoms corresponded to a negative effect on oxygen levels. The affected products were distributed worldwide, including in the United States, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay. All products manufactured since February 2012 are included in this recall.
Healthcare providers and patients should stop using the affected tracheostomy tubes and contact the manufacturer or their medical provider for instructions on replacement or further action.
The recalled product
- Product
- Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
- Affected units
- 69,461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products manufactured since 2/2012.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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