Device recall
Z-0534-2013: Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy…
FDA device recall · Class II · Arobella Medical, LLC
Key facts
| Recall number (Z-number) | Z-0534-2013 |
|---|---|
| Recall event | 63808 |
| Product | Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical… |
| Product code | LFL |
| Recalling firm | Arobella Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2015 |
| 510(k) numbers | K062544 |
| FEI number | 3007225330 |
At a glance
- 1–9 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