Device recall
Z-2206-2014: PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS…
FDA device recall · Class II · Gambro Renal Products, Incorporated
Key facts
| Recall number (Z-number) | Z-2206-2014 |
|---|---|
| Recall event | 68788 |
| Product | PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch |
| Product code | FLD |
| Recalling firm | Gambro Renal Products, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2015 |
| FEI number | 1713683 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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