Device recall
Z-0595-2021: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number…
FDA device recall · Class I · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0595-2021 |
|---|---|
| Recall event | 86804 |
| Product | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. |
| Product code | DYB |
| Recalling firm | Cook Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 7, 2022 |
| 510(k) numbers | K142829 |
| FEI number | 1820334 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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