Device recall
Z-0045-2025: Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-0045-2025 |
|---|---|
| Recall event | 95405 |
| Product | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve. |
| Product code | DYB |
| Recalling firm | Cook Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171999 |
| FEI number | 1820334 |
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