Device recall
Z-2193-2014: Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a…
FDA device recall · Class II · Gambro Renal Products, Incorporated
Key facts
| Recall number (Z-number) | Z-2193-2014 |
|---|---|
| Recall event | 68788 |
| Product | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box |
| Product code | MDP |
| Recalling firm | Gambro Renal Products, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2015 |
| PMA numbers | P830063, P830063S006 |
| 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