Device recall
Z-0116-2016: Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF…
FDA device recall · Class II · Concentric Medical Inc
Key facts
| Recall number (Z-number) | Z-0116-2016 |
|---|---|
| Recall event | 72247 |
| Product | Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in… |
| Product code | DQY |
| Recalling firm | Concentric Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2015 |
| 510(k) numbers | K133177 |
| FEI number | 3003271051 |
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