Device recall
Z-1527-2014: PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1…
FDA device recall · Class III · Laurimed LLC
Key facts
| Recall number (Z-number) | Z-1527-2014 |
|---|---|
| Recall event | 67950 |
| Product | PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established. |
| Product code | ERL |
| Recalling firm | Laurimed LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 14, 2014 |
| 510(k) numbers | K133133 |
| FEI number | 3007209822 |
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