Device recall
Z-0269-2019: REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT…
FDA device recall · Class I · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0269-2019 |
|---|---|
| Recall event | 81164 |
| Product | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support… |
| Product code | DWF |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 1, 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