Device recall
Z-1219-2019: CryoPatch SG Pulmonary Hemi-Artery Patch
FDA device recall · Class II · CryoLife, Inc.
Key facts
| Recall number (Z-number) | Z-1219-2019 |
|---|---|
| Recall event | 82380 |
| Product | CryoPatch SG Pulmonary Hemi-Artery Patch |
| Product code | DXZ |
| Recalling firm | CryoLife, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2019 |
| 510(k) numbers | K091626 |
| FEI number | 3001451326 |
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