Device recall
Z-1194-2015: NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog…
FDA device recall · Class II · Navilyst Medical, Inc
Key facts
| Recall number (Z-number) | Z-1194-2015 |
|---|---|
| Recall event | 70322 |
| Product | NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems. |
| Product code | OEQ |
| Recalling firm | Navilyst Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2017 |
| FEI number | 3017892510 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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