Device recall
Z-2101-2015: Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2101-2015 |
|---|---|
| Recall event | 71430 |
| Product | Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded… |
| Product code | DYB |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2017 |
| FEI number | 1820334 |
At a glance
- None 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