Recall record at a glance
| Official record | Z-1950-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| Report date | Jul 15, 2015 |
| Recall initiation date | May 8, 2015 |
| Quantity | 69,461 units total |
| Location | Boulder, CO, United States |
Official product description
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,
Why the product was recalled
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.
Distribution information
Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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