Device recall
Z-0180-2019: Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The…
FDA device recall · Class II · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0180-2019 |
|---|---|
| Recall event | 80930 |
| Product | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures. |
| Product code | DWF |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 15, 2021 |
| 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