Device recall
Z-1392-2017: Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1392-2017 |
|---|---|
| Recall event | 76360 |
| Product | Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices |
| 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