Device recall
Z-1390-2017: Flexor Radial Access Set, Individual product is packaged in a Tyvek-film…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1390-2017 |
|---|---|
| Recall event | 76360 |
| Product | Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures |
| Product code | DYB |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2018 |
| 510(k) numbers | K132592 |
| 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