Device recall
Z-0974-2007: Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow…
FDA device recall · Class II · Fisher & Paykel Healthcare Inc
Key facts
| Recall number (Z-number) | Z-0974-2007 |
|---|---|
| Recall event | 36955 |
| Product | Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510… |
| 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