Device recall
Z-0287-2009: NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile…
FDA device recall · Class II · Navilyst Medical
Key facts
| Recall number (Z-number) | Z-0287-2009 |
|---|---|
| Recall event | 49571 |
| Product | NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston… |
| Product code | DTZ |
| Recalling firm | Navilyst Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2009 |
| 510(k) numbers | K782095 |
| FEI number | 3017892510 |
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