The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1950-2015·Announced 2015-07-15

Shiley Neonatal and Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

FDA is recalling Shiley Neonatal and Pediatric Tracheostomy Tubes because patients reported discomfort and breathing difficulties after switching to these products.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tubes, Cuffless, manufactured by Covidien LP (formerly Nellcor Puritan Bennett Inc.). The recall covers 69,461 units distributed worldwide, including the United States, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay. The affected products were manufactured since February 2012 and include all lot numbers beginning with 12, 13, and 14.

The recall was initiated due to reports of patients experiencing discomfort and, in some cases, breathing difficulties corresponding to a negative effect on oxygen levels. These issues occurred in patients who recently switched from current Shiley Neonatal and Pediatric products to the affected units.

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, Cuffless. Model Numbers…
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)

  • 13 and 14.

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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