Device recall
Z-1539-2014: Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP…
FDA device recall · Class I · Fisher & Paykel Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-1539-2014 |
|---|---|
| Recall event | 68011 |
| Product | Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK… |
| Product code | BZO |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 30, 2014 |
| FEI number | 3002806988 |
At a glance
- None 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