Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing trac
FDA device recall Z-1951-2015 · posted 2015-07-09 · Terminated
Recall details
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- 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.
- Action taken
- Consignees were notified 5/8/15 via letter. Consignees were asked to return products.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 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.
- Date initiated
- 2015-05-08
- Date posted
- 2015-07-09
- Date terminated
- 2017-04-12
- Location
- Boulder, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T (K122531) | Covidien | 2012-10-09 |