Device recall
Z-0102-2019: Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO…
FDA device recall · Class II · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0102-2019 |
|---|---|
| Recall event | 81098 |
| Product | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO |
| Product code | DWF |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 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