Device recall
Z-0970-2007: Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks.
FDA device recall · Class II · Fisher & Paykel Healthcare Inc
Key facts
| Recall number (Z-number) | Z-0970-2007 |
|---|---|
| Recall event | 36955 |
| Product | Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. |
| Product code | BZD |
| Recalling firm | Fisher & Paykel Healthcare Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2012 |
| 510(k) numbers | K003894, K033087, K040506 |
| FEI number | 3000210616 |
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