Device recall
Z-0112-2012: Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7'…
FDA device recall · Class II · Salter Laboratories, Division of Regulatory Affairs
Key facts
| Recall number (Z-number) | Z-0112-2012 |
|---|---|
| Recall event | 58454 |
| Product | Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy. |
| Product code | BYF |
| Recalling firm | Salter Laboratories, Division of Regulatory Affairs |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2011 |
| 510(k) numbers | K772127 |
| FEI number | 1314417 |
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