Device recall
Z-0826-2014: Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic…
FDA device recall · Class II · Navilyst Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0826-2014 |
|---|---|
| Recall event | 67122 |
| Product | Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4)… |
| Product code | FPA |
| Recalling firm | Navilyst Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2017 |
| 510(k) numbers | K100720 |
| FEI number | 1000523114 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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