FDA Device recall Z-1950-2015
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless
- FDA Device
- Class I
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class I recall of Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless by Covidien Formerly Nellcor Puritan Bennett, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1950-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-05-08 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien Formerly Nellcor Puritan Bennett |
| Distribution | US |
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,
Reason
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.
Identifiers
| code_info | All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1950-2015%22
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