Device recall
Z-0192-2014: DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product…
FDA device recall · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.
Key facts
| Recall number (Z-number) | Z-0192-2014 |
|---|---|
| Recall event | 66145 |
| Product | DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional… |
| Product code | HRX |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2016 |
| 510(k) numbers | K002040, K954465 |
| FEI number | 1221934 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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