Device recall
Z-0162-2009: GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL…
FDA device recall · Class II · Smith And Nephew, Inc. Wound Management Division
Key facts
| Recall number (Z-number) | Z-0162-2009 |
|---|---|
| Recall event | 49566 |
| Product | GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China. Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and… |
| Product code | BTA |
| Recalling firm | Smith And Nephew, Inc. Wound Management Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2009 |
| 510(k) numbers | K042134 |
| FEI number | 3006760724 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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