Device recall
Z-1061-2008: Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories…
FDA device recall · Class II · Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1061-2008 |
|---|---|
| Recall event | 45545 |
| Product | Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. |
| Product code | MNS |
| Recalling firm | Respironics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2009 |
| 510(k) numbers | K020777, K071509 |
| FEI number | 2518422 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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