Device recall
Z-0816-2010: Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959…
FDA device recall · Class I · Baylis Medical Corp *
Key facts
| Recall number (Z-number) | Z-0816-2010 |
|---|---|
| Recall event | 54526 |
| Product | Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur… |
| Product code | DYB |
| Recalling firm | Baylis Medical Corp * |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 13, 2010 |
| 510(k) numbers | K013919 |
| 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