Device recall
Z-0800-2016: Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are…
FDA device recall · Class I · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0800-2016 |
|---|---|
| Recall event | 73056 |
| Product | Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH. |
| Product code | DQY |
| Recalling firm | Cook Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 23, 2017 |
| FEI number | 1820334 |
At a glance
- None 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