Device recall
Z-1951-2015: Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard…
FDA device recall · Class I · Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Key facts
| Recall number (Z-number) | Z-1951-2015 |
|---|---|
| Recall event | 71197 |
| Product | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements. |
| Product code | JOH |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 12, 2017 |
| 510(k) numbers | K122531 |
| FEI number | 2936999 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database