Device recall
Z-0899-2011: Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR…
FDA device recall · Class II · Concentric Medical Inc
Key facts
| Recall number (Z-number) | Z-0899-2011 |
|---|---|
| Recall event | 51401 |
| Product | Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral… |
| Product code | GBS |
| Recalling firm | Concentric Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2011 |
| 510(k) numbers | K021899 |
| FEI number | 3003271051 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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