Device recall
Z-0186-2022: Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0186-2022 |
|---|---|
| Recall event | 88787 |
| Product | Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator. |
| Product code | DYB |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2024 |
| 510(k) numbers | K142829 |
| 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