Device recall
Z-0834-06: Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute…
FDA device recall · Class II · Fresenius Medical Care North America
Key facts
| Recall number (Z-number) | Z-0834-06 |
|---|---|
| Recall event | 35184 |
| Product | Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028 |
| Product code | FKX |
| Recalling firm | Fresenius Medical Care North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2006 |
| 510(k) numbers | K002892 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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