Device recall
Z-1456-2015: OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO…
FDA device recall · Class I · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-1456-2015 |
|---|---|
| Recall event | 70988 |
| Product | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during… |
| Product code | DWF |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 3, 2016 |
| 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