Device recall
Z-0533-2008: Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF…
FDA device recall · Class II · Ambu Incorporated
Key facts
| Recall number (Z-number) | Z-0533-2008 |
|---|---|
| Recall event | 44734 |
| Product | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark |
| Product code | BYE |
| Recalling firm | Ambu Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2008 |
| 510(k) numbers | K782152 |
| FEI number | 1121788 |
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