Device recall
Z-1680-2014: Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical…
FDA device recall · Class II · Bacterin International, Inc.
Key facts
| Recall number (Z-number) | Z-1680-2014 |
|---|---|
| Recall event | 68305 |
| Product | Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious… |
| Product code | OEI |
| Recalling firm | Bacterin International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2014 |
| 510(k) numbers | K063245 |
| FEI number | 3005031160 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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