Device recall
Z-0936-2013: Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round…
FDA device recall · Class II · Bacterin International, Inc.
Key facts
| Recall number (Z-number) | Z-0936-2013 |
|---|---|
| Recall event | 64326 |
| Product | Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage. |
| Product code | OEI |
| Recalling firm | Bacterin International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2013 |
| 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