Device recall
Z-1912-2019: Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb…
FDA device recall · Class I · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-1912-2019 |
|---|---|
| Recall event | 82994 |
| Product | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient… |
| Product code | BZE |
| Recalling firm | Teleflex Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 22, 2024 |
| 510(k) numbers | K173280 |
| FEI number | 3005747797 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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