Device recall
Z-0811-06: MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and…
FDA device recall · Class II · Medex Inc
Key facts
| Recall number (Z-number) | Z-0811-06 |
|---|---|
| Recall event | 35119 |
| Product | MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom… |
| Product code | GWM |
| Recalling firm | Medex Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2008 |
| 510(k) numbers | K822864 |
| FEI number | 1526863 |
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