Device recall
Z-0997-2009: Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco…
FDA device recall · Class I · Covidien Limited
Key facts
| Recall number (Z-number) | Z-0997-2009 |
|---|---|
| Recall event | 51160 |
| Product | Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers. The intended use of the device is to bypass… |
| Product code | JOH |
| Recalling firm | Covidien Limited |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 21, 2012 |
| 510(k) numbers | K945513 |
| 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