Device recall
Z-0021-2018: The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a…
FDA device recall · Class I · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0021-2018 |
|---|---|
| Recall event | 78033 |
| Product | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. |
| Product code | DWF |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 29, 2024 |
| 510(k) numbers | K113869 |
| FEI number | 1000160256 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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