Device recall
Z-0653-2021: CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a…
FDA device recall · Class II · CryoLife, Inc.
Key facts
| Recall number (Z-number) | Z-0653-2021 |
|---|---|
| Recall event | 86890 |
| Product | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the… |
| Product code | DXZ |
| Recalling firm | CryoLife, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2021 |
| 510(k) numbers | K101866 |
| 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