Device recall
Z-2107-2014: Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-2107-2014 |
|---|---|
| Recall event | 68731 |
| Product | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column… |
| Product code | BTT |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2017 |
| 510(k) numbers | K031383 |
| FEI number | 3005747797 |
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