Device product
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Z-1951-2015
Product summary
- Event
- Event 71197
- Status
- Terminated
- Classification
- Class I
- Quantity
- 69,461 units total
- Official record key
device-enforcement:Z-1951-2015
Official wording
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.
Code information: All products manufactured since 2/2012.
Distribution pattern: Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Derived failure modes
-
Unknown
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.