Device recall
Z-0085-2014: Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic…
FDA device recall · Class I · Baylis Medical Corp *
Key facts
| Recall number (Z-number) | Z-0085-2014 |
|---|---|
| Recall event | 66368 |
| Product | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy… |
| Product code | DYB |
| Recalling firm | Baylis Medical Corp * |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 31, 2015 |
| 510(k) numbers | K102948 |
| FEI number | 3005241199 |
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