Device recall
Z-0165-2010: * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM…
FDA device recall · Class II · ConMed Electrosurgery
Key facts
| Recall number (Z-number) | Z-0165-2010 |
|---|---|
| Recall event | 53545 |
| Product | * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE ***** LOT 09GHL001 July 2014 MADE IN CHINA ** CONMED CORPORATION 525 FRENCH RD, UTICA, NY USA 13502" |
| Product code | GEI |
| Recalling firm | ConMed Electrosurgery |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 16, 2010 |
| 510(k) numbers | K052104 |
| FEI number | 3004491689 |
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