The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1951-2015·Announced 2015-07-15

Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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.
Manufacturer
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Category
Medical Device — Tracheostomy Tubes
Hazard
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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Covidien LP (formerly Nellcor Puritan Bennett Inc.)

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