Device recall
Z-0976-2009: Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038…
FDA device recall · Class III · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-0976-2009 |
|---|---|
| Recall event | 50548 |
| Product | Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for… |
| Product code | MJQ |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 13, 2009 |
| 510(k) numbers | K071227 |
| FEI number | 3007284006 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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