Device recall
Z-0916-03: 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which…
FDA device recall · Class II · Datascope Corp
Key facts
| Recall number (Z-number) | Z-0916-03 |
|---|---|
| Recall event | 25995 |
| Product | 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the… |
| Product code | DSP |
| Recalling firm | Datascope Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2003 |
| 510(k) numbers | K964987 |
| FEI number | 1000222374 |
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