Device recall
Z-1301-2014: Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single…
FDA device recall · Class II · Biocardia, Inc.
Key facts
| Recall number (Z-number) | Z-1301-2014 |
|---|---|
| Recall event | 67712 |
| Product | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may… |
| Product code | DYB |
| Recalling firm | Biocardia, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2014 |
| 510(k) numbers | K090999 |
| FEI number | 3003610571 |
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