Recall Z-1951-2015 ยท JOH Tube Tracheostomy And Tube Cuff
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
| Date | Jul 9, 2015 (initiated May 8, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Consignees were notified 5/8/15 via letter. Consignees were asked to return products. |
| Quantity | 69,461 units total |
| Distribution | Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T Covidien, Oct 9, 2012 |