Device recall
Z-0634-2012: STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length…
FDA device recall · Class II · ConMed Corporation
Key facts
| Recall number (Z-number) | Z-0634-2012 |
|---|---|
| Recall event | 60702 |
| Product | STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF No. S2-20 MD, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2® Secondary and Primary… |
| Product code | FPA |
| Recalling firm | ConMed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 15, 2013 |
| 510(k) numbers | K905498 |
| FEI number | 3001451571 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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