Device recall
Z-0991-2014: MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length…
FDA device recall · Class II · Biocardia, Inc.
Key facts
| Recall number (Z-number) | Z-0991-2014 |
|---|---|
| Recall event | 67492 |
| Product | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires… |
| Product code | DYB |
| Recalling firm | Biocardia, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 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