Device recall
Z-1905-2017: Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings…
FDA device recall · Class II · Breg Inc
Key facts
| Recall number (Z-number) | Z-1905-2017 |
|---|---|
| Recall event | 76994 |
| Product | Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile… |
| Product code | KGX |
| Recalling firm | Breg Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2017 |
| 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