Device recall
Z-2986-2020: Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only…
FDA device recall · Class II · Sorin Group Italia S.r.l.
Key facts
| Recall number (Z-number) | Z-2986-2020 |
|---|---|
| Recall event | 86161 |
| Product | Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval… |
| Product code | LWR |
| Recalling firm | Sorin Group Italia S.r.l. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2021 |
| FEI number | 3005687633 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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