Covidien LP (formerly Nellcor Puritan Bennett Inc.): 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.

Agency Publication Date: July 9, 2015

Affected Products

Product: Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,

All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14.

Lot Numbers:

numbers

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

All products manufactured since 2/2012.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71197

Status: Resolved

Manufacturer: Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Manufactured In: United States

Units Affected: 2 products (69,461 units total)

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Sources: FDA iRES · Raw API Response

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