Device recall
Z-0001-06: Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment…
FDA device recall · Class II · VIASYS Med Systems
Key facts
| Recall number (Z-number) | Z-0001-06 |
|---|---|
| Recall event | 33407 |
| Product | Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys… |
| Product code | FXY |
| Recalling firm | VIASYS Med Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 30, 2005 |
| 510(k) numbers | K910515 |
| FEI number | 3011270181 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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