Device recall
Z-0663-2012: Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5…
FDA device recall · Class I · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0663-2012 |
|---|---|
| Recall event | 60449 |
| Product | Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. |
| Product code | BTO |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 17, 2014 |
| 510(k) numbers | K912469 |
| FEI number | 1824231 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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