Device recall
Z-2292-2021: Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm…
FDA device recall · Class II · W L Gore & Associates, Inc.
Key facts
| Recall number (Z-number) | Z-2292-2021 |
|---|---|
| Recall event | 88245 |
| Product | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337 |
| Product code | DSY |
| Recalling firm | W L Gore & Associates, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K062161 |
| FEI number | 2017233 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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