Device recall
Z-1962-2020: Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The…
FDA device recall · Class II · W. L. Gore & Associates Inc.
Key facts
| Recall number (Z-number) | Z-1962-2020 |
|---|---|
| Recall event | 85379 |
| Product | Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ. |
| Product code | DYB |
| Recalling firm | W. L. Gore & Associates Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2020 |
| 510(k) numbers | K160254 |
| FEI number | 3007284313 |
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