Z-1950-2015 Class I Terminated
FDA device recall Z-1950-2015 was initiated by Covidien LP (formerly Nellcor Puritan Bennett Inc.) on May 8, 2015 and is designated Class I. Reason for recall: 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, correspo… The recall status is terminated (terminated April 12, 2017). Affected quantity: 69,461 units total.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2015
- Initiation Date
- May 8, 2015
- Termination Date
- April 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,461 units total
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,
Reason for Recall
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 Pattern
Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Code Information
All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14.