Device recall
Z-2326-2012: Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy…
FDA device recall · Class II · Breg Inc, An Orthofix Company
Key facts
| Recall number (Z-number) | Z-2326-2012 |
|---|---|
| Recall event | 58247 |
| Product | Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin. |
| Product code | KGX |
| Recalling firm | Breg Inc, An Orthofix Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 6, 2012 |
| FEI number | 1000125378 |
At a glance
- None 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