Device recall
Z-1634-2010: Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range…
FDA device recall · Class I · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-1634-2010 |
|---|---|
| Recall event | 55077 |
| Product | Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm… |
| Product code | BTT |
| Recalling firm | Teleflex Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 28, 2011 |
| FEI number | 3005747797 |
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