Device recall
Z-1638-2009: Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round…
FDA device recall · Class III · Aspen Surgical Products, Inc.
Key facts
| Recall number (Z-number) | Z-1638-2009 |
|---|---|
| Recall event | 51898 |
| Product | Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing. |
| Product code | GCY |
| Recalling firm | Aspen Surgical Products, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 23, 2009 |
| FEI number | 3002750084 |
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