Device recall
Z-1957-2009: Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter…
FDA device recall · Class II · Genico, Inc., dba Genicon
Key facts
| Recall number (Z-number) | Z-1957-2009 |
|---|---|
| Recall event | 50739 |
| Product | Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-010-005, 10MM (Foreign Distribution Only). A suction irrigation device. This device is used in… |
| Product code | GCY |
| Recalling firm | Genico, Inc., dba Genicon |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2009 |
| FEI number | 3002590791 |
At a glance
- None 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